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Orthopedic

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

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RecordFirmDate
TOTAL COMPRESSION PLATING (TCP) SYSTEM (K151442)Wrightmedicaltechnologyinc2015-09-04
PRO-TOE Hammertoe Fixation System (K151838)Wrightmedicaltechnologyinc2015-09-04
Xenco Medical Pedicle Screw System (K151733)Xenco Medical, LLC2015-09-04
Arcus Staple System (K151160)Nextremity Solutions, Inc.2015-09-04
Pyrenees Cervical Plate System (K152015)K2m, Inc.2015-09-04
Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15) (K150064)Orthogem, Ltd.2015-09-04
JuggerKnot Soft Anchors (K150768)Biomet Manufacturing Corp2015-09-04
CrossTIE Intraosseous Fixation System (K151270)Crossroads Extremity Systems, LLC2015-09-04
NuVasive PEEK Corpectomy Railed System (K151538)Nu Vasive, Incorporated2015-09-04
Exactech® Novation® Crown Cup® (K141960)Exactech, Inc.2015-09-03
Benefix Interspinous Fixation System (K143631)U&I Corporation2015-09-03
SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System (K151885)Depuy Synthes, Inc.2015-09-03
REDAPT¿ Revision Femoral System (K151902)Smith & Nephew, Inc.2015-09-03
Exactech Optetrak Logic Enhanced Assembly (K152170)Exactech, Inc.2015-09-03
NuVasive PEEK Corpectomy System (K151167)Nu Vasive, Incorporated2015-09-03
Lotus Posterior Cervical/Thoracic Spinal System (K151705)Spinal Elements, Inc.2015-09-03
Klassic HD Hip System (K151440)Total Joint Orthopedics, Inc.2015-09-03
Genesys Spine Apache Cervical Interbody Fusion System (K150812)Genesys Spine2015-09-03
Fortress Pedicular Fixation System (K152148)Spineology, Inc.2015-09-02
Integra Total Ankle Replacement System (K151459)Ascension Orthopedics2015-08-31
Sniper Spine System (K152174)Spine Wave, Inc.2015-08-31
Vitality Spinal Fixation System (K150896)Zimmer Spine, Inc.2015-08-31
Arthrex Fracture Plates (K151732)Arthrex, Inc.2015-08-28
PRCT2 (K143721)Fx Solutions2015-08-27
JAZZ System (K151740)Implanet, S.A.2015-08-27
NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only) (K152071)Novabone Products, LLC2015-08-26
LINK® MEGASYSTEM-C® (K151008)Waldemar Link GmbH & Co. KG2015-08-26
SALVATION® External Fixation System (K152045)Wrightmedicaltechnologyinc2015-08-21
Reform Pedicle Screw System (K151422)Precision Spine, Inc.2015-08-21
GranOSTM - beta tricalcium phosphate synthetic bone granules (K143692)Tcm Associates, Ltd.2015-08-21
STERISPINE LC CAGE (K151756)Safe Orthopaedics2015-08-21
SYNFIX Evolution Secured Spacer System (K150673)Synthes (USA) Products, LLC2015-08-21
Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm (K150648)Arthrex, Inc.2015-08-20
Frontier Medical Devices Posterior Cable Screw System (K151346)Frontier Medical Devices, Inc.2015-08-20
HA Minuteman G3 MIS Fusion Plate (K151741)Spinal Simplicity, LLC2015-08-20
Cascadia Interbody System (K150481)K2m, Inc.2015-08-20
LnK Lumbar Interbody Fusion Cage System (K151140)L&K BIOMED Co., Ltd.2015-08-18
OsteoSelect PLUS Demineralized Bone Matrix Putty (K150621)Bacterin International, Inc.2015-08-18
MASTERGRAFT Contain (K151172)Medtronic Sofamor Danek USA, Inc.2015-08-14
Foundation Interbody Devices (K150847)Corelink, LLC2015-08-13
U2 Hip Stem, Ti Porous Coated, Matrix (K151316)United Orthopedic Corporation2015-08-13
Continuum and Trilogy Integrated Taper (IT) Acetabular Systems (K151448)Zimmer, Inc.2015-08-13
Conventus PRS System (K151379)Conventus Orthopaedics, Inc.2015-08-13
Airlock® osteosynthesis plate system (K151277)Novastep2015-08-13
Aesculap T-Space PEEK and XP Spinal System (K151056)Aesculap Implant Systems, LLC2015-08-13
Arthrex BioSync® Bone Wedge (K151256)Arthex, Inc.2015-08-12
RECON system (K151407)Normed Medizin-Technik GmbH2015-08-12
SI-TECHNOLOGY® SI-DESIS® SCREWS (K151462)Si-Technology, LLC2015-08-12
Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System (K151064)Biomet Spine2015-08-12
Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides (K150928)Materialise NV2015-08-10
Everest Spinal System (K151216)K2m, Inc.2015-08-10
Restoration Anatomic Shell (K151264)Stryker Orthopaedics2015-08-10
Omega LIF System (K150395)Amendia, Inc.2015-08-10
WASTON Metallic Bone Plate and Screw Systems (K151057)Changzhou Waston Medical Appliance Co., Ltd.2015-08-10
Synchro-Medical TIGER TRACK Screw System (K151241)Synchro Medical2015-08-07
Precision Spine Interspinous Plate System (K151863)Precision Spine, Inc.2015-08-07
NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System (K151374)Nu Vasive, Incorporated2015-08-06
Medline Foot Plates and Screws (K151235)Medline Industries, Inc.2015-08-06
VariAx 2 One-Third Tubular Plating System (K151879)Stryker GmbH2015-08-06
CAPSTONE Spinal System, CLYDESDALE Spinal System (K151128)Medtronic Sofamor Danek USA, Inc.2015-08-06
MultiFIX® P Knotless Fixation Device (K151897)ArthroCare Corporation2015-08-06
SImmetry Sacroiliac Joint Fusion System (K151818)Zyga Technology, Inc.2015-08-05
ForeFoot STP System (K150871)Tornier, Inc.2015-08-04
Metallic Locking Bone Plate and Screw (K142943)Canwell Medical Co., Ltd.2015-08-03
Sniper Spine System (K151813)Spine Wave, Inc.2015-07-31
Biomet Spine Fusion System (K151483)Biomet Spine, LLC2015-07-31
LnK Posterior Cervical Fixation System (K143278)L&K BIOMED Co., Ltd.2015-07-29
Piccolo Composite Nailing System (K151010)CarboFix Orthopedics , Ltd.2015-07-28
Tyber Medical Wedge System (K150394)Tyber Medical, LLC2015-07-28
Smith and Nephew Legion Hinge Knee System (K151118)Smith & Nephew2015-07-28
Hyper-C Anterior Cervical Plate System (K150759)Degen Medical2015-07-28
2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors (K150715)Tornier, Inc.2015-07-28
Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor, Smith and Nephew Suture Anchors - Twinfix Ultra HA Suture Anchor, Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors, Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System, Ultra Fa (K151105)Smith & Nephew, Inc.2015-07-28
N-Force Fixation System (K151146)Innovision, Inc.2015-07-24
SureLock W Suture Anchor (K151068)Cayenne Medical, Inc.2015-07-24
KYPHON ELEMENT Inflatable Bone Tamp (K151532)Medtronic, Inc.2015-07-23
CinchLock Flex Knotless Suture Anchor (K151314)Pivot Medical2015-07-23
PATHWAY ELIF (K143143)Custom Spine, Inc.2015-07-22
iFuse Implant System (K150875)SI-BONE, Inc.2015-07-22
Rampart-T Interbody Fusion System (K151020)Spineology, Inc.2015-07-22
Exactech Alteon Monobloc Revision Stem (K150066)Exactech, Inc.2015-07-20
A-CIFT SoloFuse (K151198)Spinefrontier, Inc.2015-07-17
PROW FUSION (K151654)Nlt Spine, Ltd.2015-07-17
ProMIS Fixation System (K150380)Premia Spine, Ltd.2015-07-17
Refobacin Bone Cement R (K150850)Biomet, Inc.2015-07-16
MultiFIX S Knotless Fixation System (K151660)ArthroCare Corporation2015-07-16
Monster Screw System (K151418)Paragon 282015-07-15
LnK Cervical Interbody Fusion Cage System (K151677)L&K BIOMED Co., Ltd.2015-07-15
ACP 1 Anterior Cervical Plating System (K150700)Stryker Corporation2015-07-15
OsteoMed Cannulated Screw System (K151021)Osteomed Corp.2015-07-15
InFill Interbody Fusion Devices (K151184)Pinnacle Spine Group, LLC2015-07-14
Pyrenees Cervical Plate System (K150983)K2m2015-07-14
Nautilus Spinal System (K151196)Life Spine, Inc.2015-07-14
EVOS Lumbar Interbody System (K150321)Cutting Edge Spine, LLC2015-07-13
The Simple Locking IntraMedullary (SLIM) System (K143355)Pega Medical, Inc.2015-07-10
Atrax Anterior Cervical Plating System (K150834)X-Spine Systems, Inc.2015-07-10
SpineFab Vertebral Body Replacement (VBR) System (K142005)Oxford Performance Materials2015-07-10
GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle (K151037)Conmed Corporation2015-07-09
BONGOLD BONE GRAFT MATERIAL (K141725)Beijing Allgens Medical Science & Technology Co, L2015-07-09
EndoLIF On-Cage (K151143)Joimax GmbH2015-07-09
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