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Orthopedic

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

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RecordFirmDate
PFC SIGMA Knee System (K182301)DePuy Orthopaedics, Inc.2019-11-08
VK100 Percutaneous Vertebral Augmentation System (K192403)Bonwrx, Ltd.2019-11-08
Oryx Cervical Plate System (K192049)Innovasis, Inc.2019-11-08
DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile (K192327)Synthes (USA) Products, LLC2019-11-07
PRECICE Plating System (K192181)Nuvasive Specialized Orthopedics, Inc.2019-11-07
Conformis Hip System (K192198)Conformis, Inc.2019-11-06
Arthrex Nano SwiveLock Suture Anchor (K191651)Arthrex, Inc.2019-11-06
ADI TiDAL Osteotomy Wedge (K191047)Additive Device, Inc. (Adi) D/B/A Restor3D2019-11-05
Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head (K183457)Zimmer, Inc.2019-11-05
Fitmore Hip Stem (K192236)Zimmer GmbH2019-11-05
LARS AC Band Device (K190143)Corin USA2019-11-04
Idys ALIF ZP 3DTi (K192168)Clariance, Sas2019-11-04
NuVasive AttraX Putty (K191974)Nu Vasive, Incorporated2019-11-03
Parcus Knotless AP Suture Anchors (K192824)Parcus Medical, LLC2019-11-02
DePuy Corail AMT Hip Prosthesis (K190344)Depuy(Ireland)2019-11-01
XIHPOS™ ZFUZE™ Interbody Fusion System (K190544)Difusion Technologies2019-11-01
COPAL exchange G Hip and Knee Spacers (K191016)Heraeus Medical GmbH2019-11-01
Delta Multihole TT Pro Acetabular System (K191622)Lima Corporate S.P.A.2019-11-01
Small VBR™ (K192117)Ulrich GmbH & Co. KG2019-11-01
OR3O Dual Mobility System (K191002)Smith & Nephew, Inc.2019-10-31
IB3D ALIF (K191134)Medicrea International SA2019-10-30
Arthrex Low Profile Screws (K190921)Arthrex, Inc.2019-10-30
Treace Medical Concepts (TMC) Plating System (K192504)Treace Medical Concepts, Inc.2019-10-30
G21 SpaceFlex Hip (K192041)G21, S.R.L.2019-10-29
NexGen Anterior Cervical Plate System (K192494)Precision Spine2019-10-29
Black Diamond Pedicle Screw System (K192121)Osseus Fusion Systems2019-10-29
3d Cage (K180347)Fims Co., Ltd.2019-10-28
Instruments for LINK MEGASYSTEM-C Family (K190181)LinkBio Corp.2019-10-25
REDAPT Blade Augments (K190847)Smith & Nephew, Inc.2019-10-25
Genesys Spine Binary® Lumbar Plate System (K192678)Genesys Spine2019-10-24
ALTA Anterior Cervical Corpectomy System (K190426)Astura Medical, LLC2019-10-24
MediExpand TL Expandable VBR System (K190349)Cmf Medicon Surgical, Inc.2019-10-24
ADI Cervical Interbody Fusion Device (K191812)Additive Device, Inc. (Adi) D/B/A Restor3D2019-10-24
Trident II Acetabular System (K191358)Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2019-10-24
RESONATE Anterior Cervical Plate System (K192314)Globus Medical, Inc.2019-10-23
Alliance Glenoid (K191814)Zimmer, Inc.2019-10-23
FORTICO Anterior Cervical Fixation System (K191584)Camber Spine Technologies, LLC2019-10-22
Europa Pedicle Screw System (K192268)MiRus, LLC2019-10-22
Exactech Alteon Modular Dual Mobility (MDM) System (K190890)Exactech, Inc.2019-10-22
Madison Total Knee System (K192084)Implanet, S.A.2019-10-22
Fusion Silastic System (K190136)Fusion Orthopedics, LLC2019-10-21
Altapore Shape (K191513)Baxter Healthcare Corporation2019-10-19
NuVasive® Reline® 4.5-5.0 System (K190636)Nu Vasive, Incorporated2019-10-19
Arthrex SwiveLock Anchor (K192532)Arthrex, Inc.2019-10-19
NuVasive Modulus XLIF Interbody System (K192760)Nu Vasive, Incorporated2019-10-18
Arthrex SwiveLock Anchors (K192441)Arthrex, Inc.2019-10-17
Matrix HA PEEK Cervical Implant System (K192316)Sapphire Medical Group2019-10-17
Arthrex Minimally Invasive Ankle Fusion Plate (K190953)Arthrex, Inc.2019-10-16
Pitkar External Fixation System (K190486)S.H.Pitkar Orthotools Pvt. , Ltd.2019-10-16
SECURE Screw (K191771)A.M. Surgical, Inc.2019-10-16
Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module (K191326)Arthrex, Inc.2019-10-15
DualX Lumbar Intervertebral Body Fusion Device (K192434)Amplify Surgical, Inc.2019-10-15
Nano FortiCore, FortiCore (K191822)Nanovis, LLC2019-10-11
CarboClear VBR System (K192214)CarboFix Orthopedics , Ltd.2019-10-11
Zimmer Natural Nail System Cephalomedullary Nails (K192312)Zimmer GmbH2019-10-11
SMR Finned Short Stems (K191963)Lima Corporate S.P.A.2019-10-10
DigiFix Sterile Kit (K192465)Virak Orthopedics, LLC2019-10-10
Parcus Synd-EZ Ti (K191783)Parcus Medical, LLC2019-10-09
CORNICE Cervical Spacer System (K192208)Legend Spine Technologies2019-10-09
Arcadia Balloon Catheter (K191596)Merit Medical Systems, Inc.2019-10-09
Pediatric Nailing PlatformFemur (K190321)OrthoPediatrics Corp.2019-10-09
Bodycad Unicompartmental Knee System (K191150)Bodycad Laboratories, Inc.2019-10-08
32mm Glenosphere and Humeral Cup (K192206)Fx Shoulder USA, Inc.2019-10-08
Attune Revision LPS Inserts (K191779)Depuy(Ireland)2019-10-08
PROFEMUR TL2 Stems (K191632)Microport Orthopedics, Inc.2019-10-07
AFX Femoral Implant with Inserter (K192428)Cayenne Medical2019-10-05
Delta Xtend Revers Shoulder System (K192448)Depuy(Ireland)2019-10-04
Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module (K191344)Arthrex, Inc.2019-10-03
SAHARA Stabilization System (K190179)K2m, Inc.2019-10-03
CD Horizon™ Astute™ Spinal System (K191066)Medtronic Sofamor Danek USA, Inc.2019-10-03
Momentum™ Posterior Spinal Fixation System (K191932)Ulrich Medical USA2019-10-02
BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System (K192416)Zimmer GmbH2019-10-01
APTUS Wrist Spanning Plates 2.5 (K191848)Medartis AG2019-09-30
Sorrento Bone Graft Substitute (K191074)Xenco Medical, LLC2019-09-27
MiniMAX (K192352)Medacta International S.A.2019-09-27
PRECICE System (K191336)Nuvasive Specialized Orthopedics, Inc.2019-09-26
eCarbon IBDs (K191537)Back 2 Basics Direct, LLC2019-09-26
Genesys Spine Sacroiliac Joint Fusion System (K191748)Genesys Spine2019-09-26
TranS1 Interbody Fusion System (K191791)Trans12019-09-25
OMNI TiN Coated Apex Knee™ System (K191765)Omni Life Science, Inc.2019-09-25
CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System (K191212)Medos International SARL2019-09-24
Innovasis Gibralt Spine System (K192354)Innovasis, Inc.2019-09-24
USTAR II System (K190100)United Orthopedic Corporation2019-09-23
SPIRA Open Matrix ALIF and LLIF (K190483)Camber Spine Technologies2019-09-23
Hinged Laminoplasty System (K191927)Life Spine, Inc.2019-09-20
High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws (K190526)CarboFix Orthopedics , Ltd.2019-09-19
HEDRON Lumbar Spacers (K191391)Globus Medical, Inc.2019-09-18
4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage (K190563)Solco Biomedical Co., Ltd.2019-09-18
iNSitu Bipolar Hip System (K191297)Theken Companies, LLC2019-09-17
HEDRON Cervical Spacers (K191243)Globus Medical, Inc.2019-09-17
AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws (K191641)Industrias Medicas Sampedro S.A.S2019-09-16
AccelFix Lumbar Interbody Fusion Cage System (K190708)L&K BIOMED Co., Ltd.2019-09-16
Mercury® Spinal System, Overwatch® Spinal System (K191576)Spinal Elements, Inc.2019-09-16
TDM Screw Systems (K190830)Tdm Co., Ltd.2019-09-13
JuggerStitch Meniscal Repair Device (K191459)Biomet, Inc.2019-09-13
NCB Plating System Distal Femur and Proximal Tibia (K192217)Zimmer GmbH2019-09-13
Arthrex Tenodesis Button (K190288)Arthrex, Inc.2019-09-13
Republic Spine Restore Intervertebral Body Fusion System (K190398)Republic Spine, LLC2019-09-12
Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set (K191148)Medtronic Sofamor Danek USA, Inc.2019-09-12
mont blanc & mont blanc MIS Spinal Systems (K191726)Spineway SA2019-09-12
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