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Orthopedic

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

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RecordFirmDate
CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement (K231280)CarboFix Orthopedics , Ltd.2023-07-03
iFuse TORQ® Implant System (K231689)SI-BONE, Inc.2023-06-30
SGM Femoral Nail System (K230456)Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.2023-06-30
Vantage PSI System (K231585)3D Systems, Inc.2023-06-30
Ventana™ L Spinal System (K231252)Spinal Elements, Inc.2023-06-30
OsteoCentric ACL Fixation System (K230595)OsteoCentric Technologies2023-06-29
Curiteva Laminoplasty System (K231232)Curiteva, Inc.2023-06-28
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. (K231636)L&K BIOMED Co., Ltd.2023-06-27
SAGICO Spinal System (K223143)Sagico VA USA, LLC2023-06-26
Bone Bolt System (K230867)University of Utah, Department of Orthopaedics2023-06-26
AltiVate® Anatomic Shoulder AG e+™ with Markers (K222592)Encore Medical L.P.2023-06-23
PERLA® TL System; TEKTONA® HV US Bone Cement (K230774)Spineart2023-06-23
Arthrex Virtual Implant Positioning (VIP) System (K230904)Arthrex, Inc.2023-06-22
BethaLoc® stem cementless HA (K223103)Implantcast GmbH2023-06-20
CODA™ Anterior Cervical Plate System (K230993)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech2023-06-20
Solar Lumbar Interbody Fusion System (K231199)Degen Medical2023-06-16
Smart Correction System (HA Half Pins) (K231461)Wishbone Medical, Inc.2023-06-16
NuVasive Modulus ALIF System (K230894)Nu Vasive, Incorporated2023-06-16
Xerxes Hip Stem (K231109)Xerxes Arthopedix, LLC2023-06-15
Zevo Anterior Cervical Plate System (K231090)Medtronic Sofamor Danek USA, Inc.2023-06-15
EDEN Spinal Fixation MIS System (K230762)Jmt Co., Ltd.2023-06-15
TRIGEN META-NAIL Nail System (K230761)Smith & Nephew, Inc.2023-06-14
Zavation ALIF System (K230731)Zavation Medical Products, LLC2023-06-14
Axis Anterior Cervical Plate System (K231145)Southern Medical (Pty) , Ltd.2023-06-13
Cut Screw - Percutaneous Compression Screw (K230397)GM Dos Reis Industria e Comercio Ltda.2023-06-12
Acumed Acutrak 3 Headless Compression Screw System (K230744)Acumed, LLC2023-06-09
Fixone Biocomposite Anchor (K230892)Aju Pharm Co., Ltd.2023-06-09
RODIN™ Expandable Lumbar Cage System (K231359)Ctl Medical Corporation2023-06-09
Gamma4 System (K230512)Stryker GmbH2023-06-09
MyKnee UNI-ST (K231037)Medacta International S.A.2023-06-09
XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi (K222684)Stryker Spine2023-06-08
Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless) (K231002)Suzhou Endophix Co., Ltd.2023-06-07
AETOS Shoulder System (K230572)Smith & Nephew, Inc.2023-06-07
Fix2Lock(PEEK Self Punching) (K231322)Osteonic Co., Ltd.2023-06-07
Xenco Medical InterAlign Cervical Interbody System (K223059)Xenco Medical, LLC2023-06-07
TiLink-L SI Joint Fusion System (K230446)SurGenTec, LLC2023-06-07
F3D Interbody System (K230329)Corelink, LLC2023-06-06
FX V135(TM) Shoulder Prosthesis (K223801)Fx Shoulder USA, Inc.2023-06-05
Anatomic PEEK™ Cervical Fusion System with Nanotechnology (K230936)Nanovis, LLC2023-06-02
Fine Osteotomy™ (K231314)Bodycad Laboratories, Inc.2023-06-02
Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component (K230952)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2023-06-02
APTUS® 3.5 TriLock Straight Plates (K230971)Medartis AG2023-06-02
FiberTak® Suture Anchor (K231330)Arthrex, Inc.2023-06-01
Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) (K231326)Osteonic Co., Ltd.2023-05-31
Smith & Nephew ACCORD™ Cable System (K223762)Smith & Nephew2023-05-30
MyPAO Guides (K220706)Medacta International S.A.2023-05-30
Kodiak Lumbar Spacer System (K230851)Met One Technologies, LLC2023-05-26
Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS (K231233)Conformis, Inc.2023-05-26
Dark Star Deformity Pedicle Screw System (K223096)Republic Spine, LLC2023-05-26
Advanced LumFix Spinal Fixation System (K222229)CG Bio Co., Ltd.2023-05-25
KLS Martin LINOS Wrist System (K222624)KLS-Martin L.P.2023-05-25
Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath (K230874)Suzhou Endophix Co., Ltd.2023-05-23
ACTERA™ hip system (K231178)Conformis, Inc.2023-05-23
Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical interbody fusion-ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) (K230708)Gbs Commonwealth Co., Ltd.2023-05-22
Integrity™ Bone Staple Fixation System (K223860)Anika Therapeutics, Inc.2023-05-22
Klassic Knee Revision System (K230537)Total Joint Othopedics, Inc.2023-05-19
Ventana™ C Spinal System (K222833)Spinal Elements, Inc.2023-05-19
aprevo® transforaminal lumbar interbody fusion device (K231140)Carlsmed, Inc.2023-05-19
Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® (K230416)Stryker2023-05-19
Exactech® Alteon® Short Tapered Wedge (K221323)Exactech, Inc.2023-05-19
Arthrex FiberTak Suture Anchor (K231113)Arthrex, Inc.2023-05-18
JuggerKnot Soft Anchor (K231128)Riverpoint Medical, LLC2023-05-17
Eminent Spine 3D Lumbar Interbody Fusion Systems (K230219)Eminent Spine, LLC2023-05-16
EUROSCREW NG; EUROSCREW TCP NG (K230394)Teknimed2023-05-12
ClariVy™ Cervical IBF System (K230414)Vy Spine, LLC2023-05-12
JAWS Nitinol Staple System (K230550)Paragon 28, Inc.2023-05-11
Internal Joint Stabilizer - Elbow (K223318)Skeletal Dynamics, Inc.2023-05-10
Catalyst R1 Reverse Shoulder System (K223655)Catalyst Orthoscience, Inc.2023-05-09
ATEC Lateral Plate System (K230721)Alphatec Spine, Inc.2023-05-09
SIRION Lateral Lumbar Interbody System (K223335)Astura Medical2023-05-09
Latitud™ Hip Replacement System (K222436)Meril Healthcare Pvt. , Ltd.2023-05-09
ProLift Micro Expandable Spacer System (K223430)Life Spine, Inc.2023-05-04
Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates (K230653)Smith & Nephew, Inc.2023-05-04
OLYMPIC Deformity Band System (K222097)Astura Medical2023-05-04
ARIX Humerus System (K230938)Jeil Medical Corporation2023-05-03
PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw (K230655)Signature Orthopaedics Pty, Ltd.2023-05-03
Apollo Knotless Suture Anchor (K230123)Maruho Medical2023-05-03
Cortium™ (K230614)Ulrich Medical USA2023-05-02
PressON Spinal Fixation System (K223529)Nexus Spine, LLC2023-05-02
Hand Trauma Threaded Nail System (K230908)Skeletal Dynamics, Inc.2023-04-28
INTEGRATE -C Interbody Fusion System (K222004)Happe Spine2023-04-28
PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System (K222381)Stryker GmbH2023-04-27
Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert (K230844)Conformis, Inc.2023-04-27
PYXIS 3D Titanium Cage System (K223868)GS Medical Co., Ltd.2023-04-26
NITRO Interbody Fusion Cage System Family (K220513)Ctl Medical Corporation2023-04-25
ALPHALOK Plating System (K230204)Vilex, LLC2023-04-25
Kisar Stratford SI Screw System (K220274)Anjali Investments L.L.C2023-04-24
NEST-C Interbody System (K220261)Paonan Biotech Co., Ltd.2023-04-24
Kyphoplasty Balloon System (K221142)OK Medinet Korea Co., Ltd.2023-04-21
Modular Rotating Hinge Knee Systems and Compatible Components (K223069)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2023-04-21
PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System (K230808)Kyocera Medical Technologies, Inc.2023-04-21
HILINE™ Fixation System (K230565)Globus Medical, Inc.2023-04-20
ArtFX Spinal Fixation System (K212220)Artfx Medical, LLC2023-04-20
Altus Spine Monaco Pedicle Screw System (K230766)Altus Spine2023-04-19
Montross Extremity Medical Hemi Implant System (K221220)Montross Extremity Medical2023-04-19
SimpliFix Hip System (K230053)Stabiliz Orthopaedics, Inc.2023-04-19
OsteoCentric Integrated Hip Fastener System (K230764)OsteoCentric Technologies2023-04-18
UniVy™ OsteoVy™-Ti Cervical IBF System (K223513)Vy Spine, LLC2023-04-18
SnugFit All-Suture Anchor extension (K230544)Medacta International S.A.2023-04-17
TriMed Threaded Intramedullary Nail System (K230749)TriMed, Inc.2023-04-17
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