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Orthopedic

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

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RecordFirmDate
ACURA Stabilization System (K200937)Indius Medical Technologies Pvt. , Ltd.2020-10-26
AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System (K202489)Advanced Orthopaedic Solutions, Inc.2020-10-26
Cannulated Power Driver Attachment (K202528)K2m, Inc.2020-10-26
DOLOMITE Anterior Cervical Stabilization System (K202065)Astura Medical, LLC2020-10-26
Wiltrom Spinal Fixation System (K202894)Wiltrom Corporation Limited2020-10-23
Mobio Total Knee System (K202429)B-One Ortho, Corp.2020-10-23
GEO Bone Screw System (K202817)Gramercy Extremity Orthopedics, LLC2020-10-22
PRO-DENSE LoVisc Bone Graft Substitute (K200507)Wrightmedicaltechnologyinc2020-10-21
ACTIS Duofix Hip Prosthesis (K202472)DePuy Orthopaedics, Inc.2020-10-21
Trivergent Spinal Fixation System (K201427)Benvenue Medical, Inc.2020-10-21
SpineJack Expansion Kit (K202393)Stryker Corporation2020-10-20
Hexanium® ACIF (K193000)Spinevision, S.A.S.2020-10-20
AccelFix Spinal Fixation System (K200794)L&K BIOMED Co., Ltd.2020-10-20
Zavation IBF System (K200084)Zavation Medical Products, LLC2020-10-19
CD Horizon Spinal System (K202771)Medtronic2020-10-19
MUTARS Cemented Femoral Stems (K200045)Implantcast GmbH2020-10-16
OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant (K201803)OSSIO , Ltd.2020-10-16
Dall-Miles® Cable System (K202016)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2020-10-16
Cerament Bone Void Filler (K201535)Bonesupport AB2020-10-16
PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction (K202193)S.B.M. Sas (Science & Bio Materials)2020-10-16
Arthrosurface WristMotion Total Wrist Arthroplasty System (K200718)Arthrosurface, Inc.2020-10-15
Invictus™ OsseoScrew® System (K202327)Alphatec Spine, Inc.2020-10-15
icotec Anterior Cervical Plate System (K201587)Icotec AG2020-10-15
OsteoMed ExtremiFix Mini & Small Cannulated Screw System (K202680)Osteomed, LLC2020-10-15
CONSTRUX Mini PTC Spacer System (K202666)Orthofix, Inc.2020-10-14
G21 Cement, VADER® Pedicle System (K200596)Icotec AG2020-10-13
Skeletal Dynamics Ulnar Shortening Plating System (K201962)Skeletal Dynamics, Inc.2020-10-13
Zavation IBF System (K202305)Zavation Medical Products, LLC2020-10-13
Klassic Knee System Tibial Inserts, PS-Max (K202740)Total Joint Orthopedics, Inc.2020-10-09
Zeos Aqua Vision Pump and tube (K192921)Hemodia Sas2020-10-09
GAIA Lumbar Interbody Fusion Device (LIFD) Family (K201939)Printerprezz2020-10-08
LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System (K200793)L&K BIOMED Co., Ltd.2020-10-08
Piccolo Composite Proximal Tibia Plate System (K201917)CarboFix Orthopedics , Ltd.2020-10-08
Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System (K202309)Zimmer Biomet Spine, Inc.2020-10-08
Flower Suture Anchor Set (K192949)Flower Orthopedics Corporation2020-10-07
Fortilink Cages with TiPlus Technology (K201453)Paradigm Spine GmbH2020-10-07
Citregen Tendon Interference Screw and Citrelock (K200725)Acuitive Technologies2020-10-07
NuVasive® Cohere® Thoracolumbar Interbody System (K200953)Nu Vasive, Incorporated2020-10-06
Pitkar DeftFix System (K200728)S.H.Pitkar Orthotools Pvt. , Ltd.2020-10-06
R3 HA Coated Acetabular Shells (K201701)Smith & Nephew, Inc.2020-10-06
KHEIRON® Spinal Fixation System (K201659)S.M.A.I.O2020-10-05
MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides (K200792)Medacta Inernational SA2020-10-05
Materialise PKA Guide System (K202207)Materialise NV2020-10-02
Oculus-SA Lumbar Cage System (K202190)Neurostructures2020-10-02
TELEGRAPH® EVOLUTION Humeral Nailing System (K200127)FH Industrie2020-10-01
MectaScope System (K200067)Medacta International S.A.2020-10-01
Distal Centralizers (K193546)Biomet, Inc.2020-09-25
NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System (K201820)Nu Vasive, Incorporated2020-09-25
Cavetto-SA Cervical Cage System (K200115)Neurostructures, Inc.2020-09-24
Cordera Hip System (K202484)Conformis, Inc.2020-09-24
DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm (K201346)Synthes (USA) Products, LLC2020-09-23
FlareHawk TiHawk9 Interbody Fusion System (K201367)Integrity Implants, Inc.2020-09-23
Responsive Arthroscopy Interference Screw System (K202569)Responsive Arthroscopy, LLC2020-09-23
LTJ Screws and Washer (K200987)Azurmeds, Inc.2020-09-22
Accessories for the SixFix® Hexapod Fixator (K200123)Arrowhead De, LLC2020-09-22
World Hip Stem, World Cup, World Liner (K201278)Signature Orthopaedics Pty, Ltd.2020-09-21
Seaspine WaveForm C Interbody System (K201073)SeaSpine Orthopedics Corporation2020-09-18
OrthoButton FL (K202399)Riverpoint Medical2020-09-18
Smart Correction System (K193368)Wishbone Medical, Inc.2020-09-18
GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE) (K202022)Medacta International S.A.2020-09-18
Spineology Interbody Fusion System (DEN200010)Spineology, Inc.2020-09-18
SMS Cementless Stem (K201673)Medacta International S.A.2020-09-18
Life Spine SIMPACT Sacroiliac Joint Fixation System (K201538)Life Spine, Inc.2020-09-18
STRUXXURE®-L and STRUXXURE®-A Plate System (K202192)Nexxt Spine, LLC2020-09-17
Precice® Ankle Salvage System (K200430)Nuvasive Specialized Orthopedics, Inc.2020-09-16
ARIX Elbow System (K201656)Jeil Medical Corporation2020-09-15
FIREBIRD SI Fusion System (K201664)Orthofix, Inc.2020-09-15
Artus™ cervical plate system (K202227)Ulrich GmbH & Co. KG2020-09-14
FusionFrame Ring Lock System (K200343)Glw Medical Innovation2020-09-14
Shoreline ACS (Anterior Cervical System) (K201646)SeaSpine Orthopedics Corporation2020-09-14
Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System (K201506)Meditech Spine, LLC2020-09-11
DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System (K201959)DePuy Synthes2020-09-11
Dynex Micro (K202143)Vilex, LLC2020-09-11
PERFORM Humeral System – Stem (K201315)Tornier, Inc.2020-09-11
DePuy PINNACLE Dual Mobility Liner (K200854)Depuy Ireland UC2020-09-11
CD Horizon™ Spinal System (K201407)Medtronic Sofamor Danek USA, Inc.2020-09-10
X-Pac Expandable Lumbar Cage System (K201145)Expanding Innovations, Inc.2020-09-10
DePuy Synthes Variable Angle Locking Patella Plating System (K201578)Synthes (USA) Products, LLC2020-09-09
Responsive Arthroscopy Suture Anchor System (K202153)Responsive Arthroscopy, LLC2020-09-09
CD Horizon Spinal System (K202328)Medtronic Sofamor Danek USA, Inc.2020-09-08
TruLift Expandable Spacer System (K201721)Life Spine, Inc.2020-09-04
DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm (K201336)Synthes (USA) Products, LLC2020-09-03
Arthrex Syndesmosis TightRope XP Buttress Plate Implant System (K201522)Arthrex, Inc.2020-09-03
Cavetto [MAX] Cervical Cage System (K201769)Neurostructures, Inc.2020-09-03
ATL Anchors (K200503)International Life Sciences2020-09-02
Arthrex Mesh Plates (K201677)Arthrex, Inc.2020-09-02
CONFIDENCE Spinal Cement System (K201831)Depuy Spine, Inc.2020-08-31
MODULIF-A Anterior Lumbar Interbody Fusion System (K200958)Spinal Stability, LLC2020-08-28
AOS Galileo™ Trochanteric Nail System (K202099)Advanced Orthopaedic Solutions, Inc.2020-08-28
ANSER Clavicle Pin (K201830)BAAT Medical Products B.V.2020-08-27
Adaptix Interbody System with Titan nanoLOCK Surface Technology (K201267)Medtronic Sofamor Danek2020-08-26
MONDRIAN Lumbar Interbody Fusion Cage System (K192863)Ctl Medical Corporation2020-08-26
Admiral ACP System (K202064)SeaSpine Orthopedics Corporation2020-08-26
Cervical Plate System (K201979)Eminent Spine, LLC2020-08-25
Dynex Ring Fixation System, Diametrix Ring Fixation System (K202054)Vilex, LLC2020-08-24
Arthrex SwiveLock Anchor (K201749)Arthrex, Inc.2020-08-21
Hercules Suture Anchor System (K201636)In2bones USA, LLC2020-08-20
CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement (K201362)Medtronic2020-08-19
ORION Spinal System (K190600)Orion Biotech, Inc.2020-08-18
Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head (K191708)Signature Orthopaedics Pty, Ltd.2020-08-14
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