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Orthopedic

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

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RecordFirmDate
Unison-C Anterior Cervical Fixation System (K170830)Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.2017-06-28
Cannulated Screws Neoortho (K162874)Neoortho Produtos Ortopedicos S/A2017-06-27
Tranquil Interbody System (K170297)Nexus Spine, LLC2017-06-27
Distal Elbow Plating System (K171590)Skeletal Dynamics, LLC2017-06-27
Smith & Nephew 25 Fluid Management System (K171794)Smith & Nephew, Inc.2017-06-27
Swedge™ Pedicle Screw Fixation System (K170045)Spinal Resources, Inc.2017-06-26
NuVasive® CoRoent® Thoracolumbar System (K170962)Nu Vasive, Incorporated2017-06-26
PROCOTYL® PRIME Acetabular Cup System (K170444)Microport Orthopedics, Inc.2017-06-26
ReBOSSIS85 (K170620)Orthorebirth Co., Ltd.2017-06-23
AOS Anterolateral Proximal Humeral Plate (K171606)Advanced Orthopaedic Solutions, Inc. (Aos)2017-06-22
VariAx 2 Compression Plating System (K170727)Stryker GmbH2017-06-22
Terrace™ Anterior Cervical Plate System (K163104)Corelink, LLC2017-06-21
Additive Orthopaedics Bunion System (K163593)Additive Orthopaedics, LLC2017-06-20
Summit Spine Channel Cervical Interbody Fusion System (K163494)Summit Spine2017-06-20
Corin MetaFix Hip Stem (K162942)Corin U.S.A. Limited2017-06-20
Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw (K170571)Tyber Medical, LLC2017-06-20
Stryker SonicPin System (K170418)Stryker Trauma GmbH2017-06-20
Materialise Glenoid Positioning System (K170893)Materialise NV2017-06-19
Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System (K163506)Vertera, Inc.2017-06-19
Phantom Small Bone Intramedullary Nail System (K170693)Paragon 28, Inc.2017-06-19
Smith & Nephew, Inc. R3™ Constrained Liner (K162641)Smith & Nephew, Inc.2017-06-19
Cure™ Lumbar Plate System (K171538)Meditech Spine, LLC2017-06-16
BioPro Foot Plating Systems (K162674)Biopro, Inc.2017-06-16
Alians Fragment Specific (K170843)Newclip Technics2017-06-16
SeaSpine Shoreline ACS - Anterior Cervical Standalone System (K170569)SeaSpine Orthopedics Corporation2017-06-15
ATTUNE Cemented Tibial Base, Fixed Bearing (K170806)Depuy(Ireland)2017-06-15
BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell (K170288)Microport Orthopedics, Inc.2017-06-15
iTotal® Hip Replacement System (K162719)Conformis, Inc.2017-06-14
EVOS Small Fragment Lower Extremity Plates (K170457)Smith & Nephew, Inc.2017-06-14
FUSE Spinal System (K171468)Medtronic Sofamor Danek2017-06-13
Iliad® Pedicle Screw System and Zenius® Pedicle Screw System (K171509)Medyssey USA, Inc.2017-06-12
SPIRA Open Matrix ALIF (K162986)Camber Spine Technologies2017-06-12
JAZZ System, including JAZZ Band (K170730)Implanet, S.A.2017-06-09
PRECICE Intramedullary Limb Lengthening System (K170169)Nuvasive Specialized Orthopedics, Inc.2017-06-09
2-Piece Hammertoe Correction System (K162685)Life Spine, Inc.2017-06-09
SYNTEC HUMERAL NAIL SYSTEM (K161327)Syntec Scientific Corporation2017-06-08
UTF Stem, reduced, #0, #00 (K163193)United Orthopedic Corporation2017-06-08
INVISIKNOT Ankle Syndesmosis Repair Kit (K162996)Smith & Nephew, Inc.2017-06-08
Trifore(tm) Cervical Plating System (K171112)Neurostructures, Inc.2017-06-08
ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System (K170821)Choicespine, LP2017-06-08
NuVasive CoRoent Small Interlock II System (K170961)Nu Vasive, Incorporated2017-06-08
Flower Bone Screw Set (K170687)Flower Orthopedics Corporation2017-06-06
TELIX K Interbody System (K170890)Biedermann Motech GmbH & Co. KG2017-06-02
OrthoButton AL (K171060)Riverpoint Medical2017-06-02
Talos® Lumbar (HA) PEEK IBF Devices (K170395)Meditech Spine, LLC2017-06-02
Responsive Orthopedics Total Hip Arthroplasty System (K163585)Responsive Orthopedics, LLC2017-06-02
Parcus SLiK Fix Screw (K170877)Parcus Medical2017-06-02
Palisade™ Pedicular Fixation System (K171438)Spineology, Inc.2017-06-02
ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System (K170711)Zimmer GmbH2017-06-01
MATISSE Anterior Cervical Interbody Fusion Cage System (K162682)Ctl Medical Corporation2017-06-01
ALLY(TM) Bone Screws (K170698)Providence Medical Technology, Inc.2017-05-31
Empowr CR Knee Tibial Insert (K170573)Encore Medical L.P.2017-05-31
M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws (K171170)Medacta International S.A.2017-05-25
SETx Pedicle Screw System (K170611)Xenco Medical, LLC2017-05-25
FIBERGRAFT BG Putty Bone Graft Substitute (K170306)Prosidyan, Inc.2017-05-24
Fortilink™-C with TETRAfuse™ 3D Technology (K163673)Rti Surgical, Inc.2017-05-23
Smith & Nephew VISIONAIRE Adaptive Guides (K170282)Smith & Nephew, Inc.2017-05-22
SMV Scientific Cannulated Screws (K170021)Smv Scientific2017-05-22
Dymaxeon Spine System (K170989)Back 2 Basics Direct, LLC2017-05-22
DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM (K162212)Medtronic Sofamor Danek USA, Inc.2017-05-19
PIEZOTOME M+, PIEZOTOME M+ Handpiece (K163610)Satalec-Acteon Group2017-05-19
HEALIX ADVANCE Anchor with PERMATAPE Suture (K170639)Medos International SARL2017-05-18
The Solstice OCT System (K170804)Life Spine, Inc.2017-05-18
Humeris Shoulder (K163669)Fx Solutions2017-05-17
VerteFIT Corpectomy Cage System (K162133)Ldr Spine USA, Inc.2017-05-16
TRANSLACE™ Spinal Tethering System (K163181)Medtronic Sofamor Danek USA, Inc.2017-05-16
Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory (K170496)Stryker Corporation2017-05-16
Tyber Medical Wedge System (K171327)Tyber Medical, LLC2017-05-16
Arthrex Knotless SutureTak Anchor (K171020)Arthrex, Inc.2017-05-16
EPIC Extremely Small Staple (K163226)Epic Extremely, LLC2017-05-16
Piccolo Composite® Plate System (K170401)CarboFix Orthopedics , Ltd.2017-05-12
ANTHEM CR Total Knee System (K170648)Smith & Nephew, Inc.2017-05-11
Connector System (K170647)Orthofix, Inc.2017-05-11
Arthrex Compression Screws (K170382)Arthrex, Inc.2017-05-11
CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems (K170679)Medtronic Sofamor Danek2017-05-11
Orthofix TrueLok Hexapod System (TL-HEX) V2.0 (K170650)Orthofix Srl2017-05-10
MOJAVE Expandable Interbody System (K171097)K2m, Inc.2017-05-10
MALUC™ Total Hip Arthroplasty System (K162125)Surgtech, Inc.2017-05-10
I.B.S. osteosynthesis screws (K170594)In2bones Sas2017-05-10
Ocata Anterior Cervical System (K170342)Kalitec Direct, LLC2017-05-09
VariAx 2 Foot System (K170771)Stryker GmbH2017-05-08
Rampart One Lumbar Interbody Fusion Device (K163670)Spineology, Inc.2017-05-08
Precifit Medical Kirschner Wires (K163327)Precifit Medical, Ltd.2017-05-08
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System (K171082)Orthofix, Inc.2017-05-05
Colink™ Plating System (K163293)In2bones USA, LLC2017-05-05
Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor (K163672)Nanova Biomaterials, Inc.2017-05-05
SICAGE™ System (K170475)Sicage, LLC2017-05-05
Arthrex SwiveLock Anchors (K171141)Arthrex, Inc.2017-05-04
VIPER PRIME™ Screws with Fenestrations (K170543)Medos International SARL2017-05-04
Foundation 3D Interbody (K162496)Corelink, LLC2017-05-04
HALF DOME Posterior Lumbar Interbody System (K163481)Astura Medical2017-05-03
KISSloc Suture System (K170440)Arthrosurface, Inc.2017-05-03
Locking Plate System (K162380)Beijing Keyi Medical Device Technology Co., Ltd.2017-05-02
Vitoss Bioactive (BA) Injectable (K163621)Orthovita, Inc.2017-05-02
Xultan 5.5 Pedicle Screw System (K170108)Met One Technologies2017-05-02
CAPTIVATE™ Compression Screws (K162825)Globus Medical, Inc.2017-05-01
NuVasive CoRoent Ti-C System (K163707)Nu Vasive, Incorporated2017-05-01
REDAPT Sleeved Monolithic Revision Stems (K162303)Smith & Nephew, Inc.2017-05-01
The Cranial Fusion System (K162266)Life Spine, Inc.2017-05-01
Exactech® Truliant™ Line Extensions (K171045)Exactech, Inc.2017-04-28
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