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600 FDA 510(k) clearances · Product code

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RecordFirmDate
Quattro Bolt Tenodesis Screw (K143392)Cayenne Medical, Inc.2015-01-23
Stabilynx PEEK Suture Anchor (K142643)D3 Dc, LLC /Stabilynx, Inc.2014-12-15
4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, (K142574)Depuy Mitek, A Johnson & Johnson Company2014-10-24
G-Lok and G-Lok XL Extender (K142653)T.A.G. Medical Products Corporation, Ltd.2014-10-16
Apollo Suture Anchor System and Titan Screws (K142230)Valeris Medical2014-09-10
ARTHREX FIBERTAK SUTURE ANCHOR (K140476)Arthrex, Inc.2014-08-13
G-FORCE GEN 2 SUTURE ANCHOR SYSTEM (K141011)Wrightmedicaltechnologyinc2014-07-30
PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE SUTURE, PONTIS ULTRA-HIGH MOLECULAR WEIGHT POLYE (K141711)Pontis Orthopaeeics, LLC2014-07-24
BIOSURE HEALICOIL PK INTERFERENCE SCREW (K140879)Smith & Nephew, Inc.2014-07-21
RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL (K140324)Depuy Mitek, A Johnson and Johnson Company2014-07-07
MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS (K133579)Pontis Orthopaedics, LLC2014-06-26
ACUMED SUTURE ANCHOR SYSTEM (K140925)Acumed, LLC2014-05-20
MULTIFIX S KNOTLESS FIXATION SYSTEM (K140604)ArthroCare Corporation2014-05-14
ICONN ANSWER SUTURE ANCHOR (K132724)Iconn Orthopedics, LLC2014-04-17
THREADED PEEK K-WIRE (K133235)Mtp Solutions, LLC2014-04-07
TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR (K133777)Tornier, Inc.2014-04-04
N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL (K133606)ArthroCare Corporation2014-04-01
ACUMED SUTURE ANCHOR SYSTEM (K133469)Acumed, LLC2014-03-10
APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS (K133036)Amendia, Inc.2014-03-06
ICONIX ALL SUTURE ANCHORS (K133671)Stryker Corp.2014-02-28
GFS II STANDARD, GFS II LARGE, GFS MIMI (K133757)Parcus Medical, LLC2014-02-04
TITANIUM SUTURE ANCHOR (K133229)Mtp Solutions, LLC2014-01-30
Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM, FIRSTPASS SUTU (K133727)ArthroCare Corporation2014-01-16
Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2 HIFI SUTURES (K133224)Conmed Corporation2014-01-03
SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM (K132867)Cayenne Medical, Inc.2013-12-30
EXOSHAPE DUO SOFT TISSUE FASTENER (K132783)MedShape, Inc.2013-12-09
POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE (K130467)MedShape, Inc.2013-12-05
NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS (K122437)Biomet Sports Medicine2013-10-18
A.I.M. SUTURE ANCHOR (K132461)Anchor Innovation Medical, Inc.2013-10-16
CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM (K131769)Pivot Medical, Inc.2013-10-07
Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER (K132513)ArthroCare Corporation2013-09-19
TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES (K132632)Tornier, Inc.2013-09-19
5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, INSERTION GUIDE WITH OBTURATOR, TA (K132590)ArthroCare Corporation2013-09-17
ROTATION MEDICAL BONE STAPLE (RMB STAPLE) (K131635)Rotation Medical, Inc.2013-08-29
QUATTRO GL SUTURE ANCHOR (K131325)Cayenne Medical, Inc.2013-08-16
RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM (K130814)Depuy Mitek, A Johnson & Johnson Company2013-08-01
TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO (K130033)Biomet Manufacturing Corp2013-08-01
MULTIFIX S KNOTLESS FIXATION DEVICE (K131182)Arthocare Corporation2013-07-29
Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM (K131035)Linvatec Corporation D/B/A Conmed Linvatec2013-07-02
HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM) (K131683)Depuy Mitek, Inc., A Johnson and Johnson Company2013-06-27
ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM (K130217)OrthoPediatrics Corp.2013-06-20
HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM) (K130539)Depuy Mitek, A Johnson & Johnson Company2013-05-21
KNOTLESS FIBERTAK SUTURE ANCHOR (K130458)Arthrex, Inc.2013-05-03
ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS (K122059)Smith & Nephew, Inc.2013-03-18
JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF (K123485)Biomet Sports Medicine2013-03-18
NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER (K130351)Pivot Medical, Inc.2013-03-14
ECLIPSE SOFT TISSUE FASTENER (K123350)MedShape, Inc.2013-03-07
COLS® FIXATION SYSTEM (K120740)Fournitures Hospitalieres Industrie2013-03-05
SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR (K130196)Arthrocare Corp.2013-02-27
CINCHLOCK KNOTLESS SUTURE ANCHOR (K123651)Pivot Medical2013-02-21
TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL (K123425)Smith & Nephew, Inc.2013-02-20
SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT (K123240)ArthroCare Corporation2013-02-14
PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR (K122805)Parcus Medical, LLC2013-02-05
FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL (K123579)Smith & Nephew, Inc.2013-01-23
Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM (K122336)Eleven Blade Solutions, Inc.2013-01-09
ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTON (K123341)Arthrex, Inc.2012-12-21
CINCHER-2.6 SUTURE ANCHOR MODEL FG-001 (K122954)Foundry Newcoxi, Inc.2012-12-19
NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD (K120356)Ncs Lab Srl2012-12-11
MICRO/MINI N-PK(H) BONE ANCHOR (K121356)Anulex Technologies, Inc.2012-11-09
MICRO/MINI N-PK(F) BONE ANCHOR (K121354)Anulex Technologies, Inc.2012-11-09
QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY (K122314)Cayenne Medical, Inc.2012-10-31
APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W (K122463)Cayenne Medical, Inc.2012-10-11
6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED (K122123)Depuy Mitek, Inc., A Johnson and Johnson Company2012-10-02
SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL SPEEDLOCK HIP GUIDE CROWN TIP SPEEDLOCK HIP PATHFINDER (K120943)ArthroCare Corporation2012-09-21
STRYKER ALL SUTURE ANCHORS (K120509)Stryker2012-07-26
3.9MM REELX STT SUTURE ANCHOR SYSTEM (K120824)Stryker Corp.2012-07-18
BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN (K121018)Smith & Nephew, Inc.2012-06-22
APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR (K120841)Kfx Medical2012-06-07
PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC (K120942)Parcus Medical, LLC2012-04-20
MULTIFIX P KNOTLESS FIXATION DEVICE (K120096)ArthroCare Corporation2012-03-27
FOOTPRINT ULTRA PK SUTURE ANCHOR (K113274)Smith & Nephew, Inc.2012-03-06
KNOTILUS ANCHOR SYSTEM (K113297)T.A.G. Medical Products Corporation, Ltd.2012-03-02
ARTHREX KNOTLESS SUTURETAK ANCHOR (K120155)Arthrex, Inc.2012-02-17
TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS (K112526)Smith & Nephew, Inc.2012-01-31
SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR (K113294)Smith & Nephew, Inc.2012-01-20
CUFFINK (K112814)Cayenne Medical, Inc.2012-01-17
PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS (K113730)Parcus Medical, LLC2012-01-17
VARIOUS (K112417)Depuy Mitek, A Johnson & Johnson Company2012-01-13
LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTURE (K112960)Cayenne Medical, Inc.2012-01-09
ROG SUTURE ANCHOR (K113299)Rog Sports Medicine, Inc.2011-12-15
CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5 (K112876)Cayenne Medical, Inc.2011-12-15
MODIFIED ROG SUTURE ANCHOR (K112991)Rog Sports Medicine, Inc.2011-12-08
LATERAL BUTTON (K112296)T.A.G. Medical Products Corporation, Ltd.2011-12-01
KNOTLESS SUTURE FIXATION SYSTEM (K111716)Core Essence Orthopaedics2011-11-10
NANO SUTURE ANCHOR (K112965)Linvatec Corporation D/B/A Conmed Linvatec2011-11-02
META-LOCK SUTURE ANCHOR SYSTEM (K110800)Tarsus Medical, Inc.2011-09-27
ARTHREX SCAPHOLUNATE ANCHOR (K111661)Arthrex, Inc.2011-08-19
BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR (K110879)Biomet Sports Medicine2011-08-19
SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE (K111044)ArthroCare Corporation2011-08-09
Y-KNOT ALL-SUTURE ANCHOR MODEL HF13 (K111779)Conmed Linvatec2011-08-08
ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR (K111590)Rog Sports Medicine, Inc.2011-08-08
GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN.. (K111631)Depuy Mitek, A Johnson & Johnson Company2011-07-22
SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75 (K111399)Arthrocare Corp.2011-07-20
TITAN TI SUTURE ANCHOR SYSTEM (K111397)Arthrocare Corp.2011-07-12
SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK) (K110545)Smith & Nephew, Inc.2011-06-24
MAXFIRE MARXMEN MENISCAL REPAIR DEVICE (K111564)Biomet Sports Medicine2011-06-16
EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE) (K111471)Medshape Solutions, Inc.2011-06-10
TORNIER INSITE FT SUTURE ANCHOR (K110773)Tornier, Inc.2011-06-02
5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP (K110781)Arthrocare Corp.2011-05-27
NANOTACK SUTURE ANCHOR 1.4MM (K110473)Pivot Medical2011-05-25
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