Atlas FDA

Orthopedic

17,044 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM (K122901)Orthofix2012-12-03
PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM (K123207)Osteomed LP2012-11-29
CONSTRUX MINI PEEK TI SPACER SYSTEM (K121649)Orthofix2012-11-29
CHECKMATE SMALL BONE FUSION SYSTEM (K122334)Arthrosurface, Inc.2012-11-28
OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC, (K121989)Exactech, Inc.2012-11-27
MERETE LOCKING BONE PLATE SYSTEM III (K120787)Merete Medical GmbH2012-11-27
STABILIZ FIXATION SYSTEM (K120651)Stabiliz Orthopaedics, LLC2012-11-27
PICCOLO COMPOSITE PLATE SYSTEM (K120409)CarboFix Orthopedics , Ltd.2012-11-26
G7 ACETABULAR SYSTEM (K121874)Biomet Manufacturing Corp2012-11-23
CORIN TRINITY-I ACETABULAR SHELL (K122305)Corin USA2012-11-21
EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT (K121220)Exactech, Inc.2012-11-20
S-LOK PSS SYSTEM (K122931)Spinal USA2012-11-20
ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS (K122596)Smith & Nephew, Inc.2012-11-20
COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM (K123297)Biomet Manufactuting Corp.2012-11-20
VICEROY SPINAL SYSTEM (K122229)Torrey Spine2012-11-20
ZOU ANTERIOR LUMBAR PLATE SYSTEM (K121791)Corelink, LLC2012-11-19
ACUMED PELVIC BONE PLATE SYSTEM (K122538)Acumed, LLC2012-11-19
LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPING (K121494)Aap Implantate AG2012-11-19
CD HORIZON SPIRE Z SPINAL SYSTEM (K123246)Medtronic Sofamor Danek2012-11-16
PRO-LINK CERVICAL SPACER SYSTEM (K121151)Life Spine, Inc.2012-11-16
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE (K122529)Zimmer, Inc.2012-11-16
INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE (K122008)Incite Innovation, LLC2012-11-16
SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY (K113728)Hans Biomed Corp.2012-11-15
KLS MARTIN RECON TALON (K122860)KLS Martin L.P.2012-11-14
VERTIFLEX DIRECT DECOMPRESSION SYSTEM (K122662)Vertiflex, Inc.2012-11-13
MICRO/MINI N-PK(H) BONE ANCHOR (K121356)Anulex Technologies, Inc.2012-11-09
H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS (K112091)Lima Corporate S.P.A.2012-11-09
MICRO/MINI N-PK(F) BONE ANCHOR (K121354)Anulex Technologies, Inc.2012-11-09
PERSONA NATURAL TIBIA BASEPLATES (K122765)Zimmer, Inc.2012-11-09
AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM (K113601)Aap Implantate AG2012-11-08
ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM (K121771)Zimmer, Inc.2012-11-07
HAMMER TOE IMPLANT (K122959)Trilliant Surgical, Ltd.2012-11-07
GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET (K122738)Solana Surgical, LLC2012-11-07
Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE (K121277)Z-Medical GmbH & Co. KG2012-11-07
PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM (K121725)Pioneer Surgical Technology, Inc.2012-11-07
CS2 HIP SYSTEM (K122512)Consensus Orthopedics, Inc.2012-11-05
TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT (K121509)Tgm Medical, Inc.2012-11-05
DYMAXEON SPINE SYSTEM (K121786)B2b Spine Pty, Ltd.2012-11-05
REVELATION POROUS COATED HIP STEM, SIZE 8 (K122636)Encore Medical L.P.2012-11-02
FRONTIER SADL INTERBODY FUSION DEVICE (K112700)Frontier Medical Devices, Inc.2012-11-01
CERTEX SPINAL IMPLANT SYSTEM (K122163)X-Spine Systems, Inc.2012-10-31
QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY (K122314)Cayenne Medical, Inc.2012-10-31
DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS (K122395)DePuy Orthopaedics, Inc.2012-10-31
REX ANTERIOR CERVICAL PLATE SYSTEM (K121862)Dio Medical Co., Ltd.2012-10-31
CANOPY LAMINOPLASTY FIXATION SYSTEM (K121732)Globus Medical, Inc.2012-10-31
AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM (K113602)Aap Implantate AG2012-10-31
BIOPRO HEMI-EDGE TOE SYSTEM (K121973)Biopro, Inc.2012-10-30
COLUMBUS REVISION KNEE SYSTEM (K122985)Aesculap Implant System, Inc.2012-10-26
ANCHOR-L LUMBAR CAGE (K120869)Stryker Spine2012-10-25
FUSELOX LUMBAR INTERBODY FUSION DEVICE (K122956)Captiva Spine2012-10-25
SHAPEMATCH CUTTING GUIDE (K122053)Stryker Corp.2012-10-24
HOFFMANN 3 (K122284)Stryker Corp.2012-10-24
ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT (K121636)Tgm Medical, Inc.2012-10-24
RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM (K122292)Reliance Medical Systems, LLC2012-10-24
SMITH & NEPHEW SMF HIP STEM (K123012)Smith & Nephew, Inc.2012-10-24
BIOMET LATERAL SPACER SYSTEM (K122989)Biomet Spine (Aka Ebi, LLC)2012-10-24
INTRAMEDULLARY NAIL SYSTEM (K121312)Weigao Orthopaedic Device Co., Ltd.2012-10-24
OSSEOFLEX SB INFLATABLE BONE TAMP (K122533)Osseon Therapeutics, Inc.2012-10-23
NUVASIVE SAGE LATERAL PLATE SYSTEM (K121815)Nuvasive, Inc.2012-10-23
FORTEX PEDICLE SCREW SYSTEM (K120832)X-Spine Systems, Inc.2012-10-23
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS (K123019)Zimmer, Inc.2012-10-22
DYNASTY BIOFOAM SHELL (K122382)Wrightmedicaltechnologyinc2012-10-22
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM (K122277)Biomet Manufacturing Corp2012-10-22
VERTECEM II CEMENT KIT (K121876)Aap Biomaterials GmbH2012-10-19
SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION (K122170)Smith & Nephew, Inc.2012-10-19
ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM (K113219)Ellipse Technologies, Inc.2012-10-19
VERSAFITCUP CC TRIO EXTENSION (K122911)Medacta International2012-10-19
4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM) (K121741)4-Web, Inc.2012-10-18
COUGAR LS 15 LATERAL CAGE SYSTEM (K122896)Medos International SARL2012-10-18
BOX PEEK VBR SYSTEM, (K121581)Innovasis, Inc.2012-10-17
STINGRAY CERVICAL CAGE (K122085)Omni Surgical, LP Dba Spine3602012-10-17
TOWERLOX PEDICLE SCREW SYSTEM (K122332)Captiva Spine2012-10-16
SMITH & NEPHEW R3 CONSTRAINED LINERS (K122139)Smith & Nephew, Inc.2012-10-16
SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM (K121627)Smith & Nephew, Inc.2012-10-15
ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM (K122497)Medical Design, LLC2012-10-15
IFUSE IMPLANT SYSTEM (K122074)SI-BONE, Inc.2012-10-12
PIONEER STERNAL CABLE PLATE SYSTEM (K122293)Pioneer Surgical Technology, Inc.2012-10-12
ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM (K121651)Wrightmedicaltechnologyinc2012-10-12
TREGOR DUAL MOBILITY ACETABULAR SYSTEM (K111981)Aston Medical2012-10-12
UNISYN PLUS HIP STEM (K120595)Consensus Orthopedics, Inc.2012-10-12
INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL (K122798)Exactech, Inc.2012-10-11
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS (K121543)Zimmer, Inc.2012-10-11
CAPSURE(R) PS SYSTEM (K122233)Spine Wave, Inc.2012-10-11
PROFEMUR Z REVISION HIP STEM (K122778)Wrightmedicaltechnologyinc2012-10-11
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
ARCHON ANTERIOR CERVICAL PLATE SYSTE, (K122910)Nu Vasive, Incorporated2012-10-11
VISUALIF CHALLENGING ACCESS PLATE (K122168)Spine Smith Partners L.P.2012-10-11
FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH (K122504)United Orthopedic Corporation2012-10-10
CROSS-OVER ACETABULAR SHELL & LINER (K122773)Stelkast Company2012-10-09
VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE) (K112837)Vilex, Inc.2012-10-09
NEXTRA TI HAMMERTOE CORRECTION SYSTEM (K122031)Nextremity Solutions, LLC2012-10-09
BENCOX II STEM, BENCOX METAL HEAD (K122099)Corentec Co., Ltd.2012-10-05
SMITH & NEPHEW RADIOPAQUE TRIAL NECKS (K113039)Smith & Nephew, Inc.2012-10-05
ALAMO T (K120401)Alliance Partners, LLC2012-10-05
CORIN TRIFIT TS HIP (K121563)Corin USA2012-10-05
TIGER SPINE SYSTEM (K121728)Corelink, LLC2012-10-05
TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE (K122366)Spineart2012-10-04
ACTIVE SCREW BONE SCREW (K121682)Intelligent Implant Systems, LLC2012-10-04
CD HORIZON SPINAL SYSTEM (K122862)Medtronic Sofamor Danek USA, Inc.2012-10-03
GEMINUS FOSSA SPECIFIC PLATE SYSTEM (K122737)Skeletal Dynamics, LLC2012-10-03
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