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Orthopedic

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

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RecordFirmDate
DynaNail TTC Fusion System (K171376)MedShape, Inc.2017-11-02
SOVEREIGN™ Spinal System (K172328)Medtronic Sofamor Danek USA, Inc.2017-11-02
Medussa-PL Cage (K170341)Medyssey USA, Inc.2017-11-02
Sapphire Cervical Implant System (K172674)Sapphire Medical Group2017-11-02
GMK Hinge, GMK Revision (K172347)Medacta International S.A.2017-11-01
Paramount Anterior Cervical Cage System (K173175)Spine Wave, Inc.2017-11-01
IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) (K173080)Huvexel Co. , Ltd.2017-10-31
Trinity™ Dual Mobility System (K170359)Corin U.S.A. Limited2017-10-31
Flex-Thread Fibula Pin System (K172943)Intrafuse, LLC2017-10-30
Bi-Ostetic Bioactive Glass Foam (K170917)Berkeley Advanced Biomaterials2017-10-30
Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (K172326)Stryker Orthopaedics2017-10-30
AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert (K172351)Encore Medical L.P.2017-10-30
Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly (K173104)Total Joint Orthopedics, Inc.2017-10-27
NuVasive® Modulus TLIF Interbody System (K172341)Nu Vasive, Incorporated2017-10-26
SeaSpine Ventura NanoMetalene System (K173022)SeaSpine Orthopedics Corporation2017-10-26
Omnia Medical VBR (K172323)Omnia Medical, LLC2017-10-26
SILC® Fixation System (K172417)Globus Medical, Inc.2017-10-26
Cortina™ Lumbar Cage System (K171914)Neurostructures, Inc.2017-10-25
Treace Medical Concepts (TMC) Compression Screw System (K172617)Treace Medical Concepts, Inc.2017-10-25
VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with Fenestrations (K173095)Medos International SARL2017-10-25
CosmoLock Pedicle Screw System (K172808)Kalitec Direct, LLC2017-10-25
Ortus™ Expandable Lumbar Interbody Fusion System (K172334)Atlas Spine, Inc.2017-10-25
UTS Stem (K172251)United Orthopedic Corporation2017-10-24
G3™ Active Plate® Miniature System (K171293)Genesis Fracture Care, Inc.2017-10-23
M-ARS ACL: Anatomic Ribbon Surgery System (K171640)Medacta International S.A.2017-10-23
Acapella Cervical Spacer System (K171489)Choicespine, LP2017-10-23
KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set (K171938)Medtronic2017-10-23
IRENE Cannulated Screw System (K170056)Tianjin Zhengtian Medical Instrument Co., Ltd.2017-10-23
AnyPlus® Spinal Fixation System (K172546)GS Medical Co., Ltd.2017-10-23
Liberty Anterior Cervical Plate (K172585)Valorus Spine2017-10-23
Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology (K172343)Rti Surgical, Inc.2017-10-23
MECRON Cannulated Screw System (K172213)Merete GmbH2017-10-23
MyKnee PPS-Pin Positioners (K170106)Medacta International S.A.2017-10-20
Bencox Mirabo Cup System (K172806)Corentec Co., Ltd.2017-10-17
BioWick X Implant with Driver (K172186)Cayenne Medical, Inc.2017-10-16
NOVOS-NAIL Limb Lengthening System (LLS) (K163653)Smith & Nephew2017-10-13
Galaxy UNYCO System (K170146)Orthofix Srl2017-10-12
Mikron Spinal Fixation System (K171497)Mikron Makina Sanayi Ticaret Co. , Ltd.2017-10-12
NuVasive® Modulus XLIF Interbody System (K172123)Nu Vasive, Incorporated2017-10-11
XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory (K172724)Stryker Corporation2017-10-10
U-Motion II Acetabular System— Additional sizes (K170089)United Orthopedic Corporation2017-10-06
Shanghai Sanyou CARMEN Cervical Fusion System (K163366)Shanghai Sanyou Medical Co, Ltd.2017-10-05
Biomet Bone Cement R (K172408)Biomet, Inc.2017-10-05
Medacta Shoulder System (K170452)Medacta International S.A.2017-10-05
Tahoe Uni Knee System (K170344)Consensus Orthopedics, Inc.2017-10-05
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology (K171689)Medtronic Sofamor Danek USA, Inc.2017-10-05
EMPOWR Porous Knee System (K171991)Encore Medical L.P.2017-10-04
Reprocessed Shavers/Burs (K172092)Renovo, Inc.2017-10-04
Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem (K172684)Smith & Nephew, Inc.2017-10-03
BRIDALVEIL Occipital Cervical Thoracic System (K171250)Astura Medical2017-10-02
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (K172210)Stryker Trauma AG2017-10-02
Large Screws Range (K172596)Newclip Technics2017-10-02
Trident® II Acetabular System (K171768)Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2017-10-02
Calix Lumbar Spinal Implant System (K170119)X-Spine Systems, Inc.2017-09-29
SCARLET AC-T (K172065)Spineart2017-09-29
NuVasive TLX Interbody System (K171633)Nu Vasive, Incorporated2017-09-28
FiberTak DX (K172612)Arthex, Inc.2017-09-28
TRAUMACEM™ V+ Injectable Bone Cement (K170802)Synthes (USA) Products, LLC2017-09-28
NuVasive® Precept™ Spinal System (K171894)Nu Vasive, Incorporated2017-09-28
Vitality® Spinal Fixation System, Vitality®+ Power Instrument System (K172275)Zimmer Biomet Spine, Inc.2017-09-27
Spider Frame External Fixation System (K170482)Tasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S2017-09-27
OIC External Fixation System (K171211)Orthopaedic Implant Company2017-09-27
CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System (K171107)Medtronic Sofamor Danek USA, Inc.2017-09-26
ROMEO® 2 Posterior Osteosynthesis System (K172101)Spineart2017-09-26
Ecofit® Hip System (K163577)Implantcast GmbH2017-09-25
PRECICE System (K172628)Nuvasive Specialized Orthopedics, Inc.2017-09-25
Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) (K171161)Dimensional Bioceramics, LLC2017-09-25
INDEPENDENCE® Spacers (K170157)Globus Medical, Inc.2017-09-25
Matira™ Anterior Cervical System (K172086)Kalitec Direct, LLC2017-09-22
ARIX Wrist System (K170705)Jeil Medical Corporation2017-09-21
DARCO Locking Bone Plate System (K171852)Wrightmedicaltechnologyinc2017-09-21
iNSitu Total Hip System (K172501)Theken Companies, LLC2017-09-21
PMT Posterior Fixation System (K172279)Providence Medical Technology, Inc.2017-09-20
ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium (K172199)Medtronic Sofamor Danek2017-09-19
LigaMetrics Suture Anchors (K171964)Mortise Medical, LLC2017-09-19
Shanghai Sanyou PEEK Cage System (K163422)Shanghai Sanyou Medical Co, Ltd.2017-09-18
Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers (K172587)Medacta International S.A.2017-09-18
FLXfit™ (K171519)Expanding Orthopedics, Inc.2017-09-15
Ti-Diagon Oblique TLIF (K172064)Camber Spine Technologies2017-09-15
Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System (K171686)Choicespine2017-09-15
Shotel Ankle Arthrodesis Nail System (K163627)Biopro, Inc.2017-09-14
Range/Denali/Mesa Spinal System (K171832)K2m, Inc.2017-09-14
BePOD® Foot Screws (K163148)Fournitures Hospitalieres Industrie2017-09-14
NEO Pedicle Screw System™ (K171582)Neo Medical SA2017-09-12
INVISION Total Ankle Revision System (K171067)Wrightmedicaltechnologyinc2017-09-11
CuffLink Implant System (K171725)Conmed Corporation2017-09-08
The Locking Pediatric Osteotomy Plate (LolliPOP) System (K170704)Pega Medical, Inc.2017-09-08
Footmotion Plating System (K171510)Newclip Technics2017-09-08
BePOD® EZ Weil Screws (K163710)Fournitures Hospitalieres Industrie2017-09-08
APTUS(R) Wrist 2.5 System (K172170)Medartis AG2017-09-08
Posterior Spine Truss System (PSTS) Interbody Fusion Device (K171351)4Web, Inc.2017-09-08
Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate) (K171893)Bluestone Synergy2017-09-08
Reliance Cervical IBF System (K172489)Reliance Medical Systems, LLC2017-09-07
T-Rex Standalone ALIF (K170855)Siats, LLC2017-09-07
S4 Screw System™ (K162171)Subchondral Solutions2017-09-07
Tritanium C Anterior Cervical Cage (K171496)Stryker Spine2017-09-06
Arthrex Mesh Plate System (K170547)Arthrex, Inc.2017-09-01
ExsoMed ITN Cannulated Screw System (K171558)Exsomed Holdings Company, LLC2017-09-01
CAPRI Corpectomy Cage System (K171704)K2m2017-08-31
Latitude EV Total Elbow Arthroplasty (K171010)Tornier, Inc.2017-08-31
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