Atlas FDA

Orthopedic

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

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RecordFirmDate
Journey II XR Knee Instrument (K200227)Smith & Nephew, Inc.2020-06-04
AltiVate Anatomic Canal-Sparing (CS) Shoulder (K193226)Encore Medical L.P.2020-06-03
Altus Spine Pedicle Screw System (K200322)Altus Partners, LLC2020-06-02
Skeletal Dynamics Forearm Plating System (K200538)Skeletal Dynamics, Inc.2020-06-01
Idys ALIF ZP 3DTi (K200920)Clariance, Sas2020-05-29
KONG-TL VBR System, KONG-C VBR System (K200235)Icotec AG2020-05-29
Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device (K200002)4Web, Inc.2020-05-29
Meridian Anterior Plate System, Regatta Lateral Plate System (K200885)SeaSpine Orthopedics Corporation2020-05-28
Joline Kyphoplasty System Allevo (K192449)Joline GmbH & Co. KG2020-05-27
Restoration® Modular Hip System (K193233)Howmedica Osteonics Corp. (Aka Stryker Orthopaedics)2020-05-27
VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 (K193423)Icotec AG2020-05-22
Invictus™ CT Spinal Fixation System (K200936)Alphatec Spine, Inc.2020-05-22
JPS JuniOrtho Plating System (K200246)Orthofix Srl2020-05-22
NEXXT MATRIXX System (K200969)Nexxt Spine, LLC2020-05-21
Insignia™ Anterior Cervical Plate System (K200995)Alphatec Spine, Inc.2020-05-21
NuVasive Thoracolumbar Plates (K200956)Nu Vasive, Incorporated2020-05-21
Axis Spine Technologies ALIF (K200352)Axis Spine Technologies, Ltd.2020-05-20
NuVasive® ACP System (K201078)Nu Vasive, Incorporated2020-05-20
Reform Pedicle Screw System (K200303)Precision Spine2020-05-19
MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF (K191906)MiRus, LLC2020-05-18
Biocore9 Humeral Resurfacing System (K193122)Biocore9, LLC2020-05-15
Skeletal Dynamics Midshaft Humerus Plating System (K200701)Skeletal Dynamics, Inc.2020-05-14
KeYi Total Hip System (K191826)Beijing Keyi Medical Device Technology Co., Ltd.2020-05-14
Distal Humerus Plating System (K200367)Skeletal Dynamics, Inc.2020-05-14
EVOL Spinal Interbody System (K200991)Cutting Edge Spine, LLC2020-05-13
Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite (K200782)Howmedica Osteonics Corp.2020-05-13
InCore MPJ System (K200124)Nextremity Solutions, Inc.2020-05-13
Dymaxeon Spine System (K192930)Back 2 Basics Direct, LLC2020-05-12
AUDERE Lumbar Spacer System (K193457)Met One Technologies2020-05-12
Cure™ Lumbar Plate System (K201136)Meditech Spine, LLC2020-05-12
Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) (K200290)SeaSpine Orthopedics Corporation2020-05-11
Precice® Screws (K193617)Nuvasive Specialized Orthopedics, Inc.2020-05-08
ALTAPORE SHAPE (K200640)Baxter Healthcare Corporation2020-05-08
PRECICE Bone Transport System (K193016)Nuvasive Specialized Orthopedics, Inc.2020-05-08
Treace Medical Concepts (TMC) Plating System (K200961)Treace Medical Concepts, Inc.2020-05-08
LOSPA II Knee System (EXULT Knee Replacement System) (K200395)Corentec Co., Ltd.2020-05-07
AMF Revision TT Cones (K200653)Lima Corporate S.P.A.2020-05-07
Syntec Non-Sterile Steinmann Pins System (K200933)Syntec Scientific Corporation2020-05-05
Balteum™ Lumbar Plate System (K200846)Huvexel Co. , Ltd.2020-05-05
Healix Compression Screw System (K200914)Nvision Biomedical Technologies, Inc.2020-05-05
Headless Compression Screw System (K200259)Osteocentric Extremities, LLC2020-05-04
PERLA® Posterior Occipito-Cervico-Thoracic Fixation System (K200571)Spineart2020-05-01
OGmend Implant System (DEN180065)Woven Orthopedic Technologies, LLC2020-05-01
SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices (K200816)Spineex, Inc.2020-04-30
Biolign® Roto-Loc Cervical Plate System (K200523)Elite Surgical Supplies (Pty), Ltd.2020-04-30
CarboClear® II Pedicle Screw System (K200519)CarboFix Orthopedics , Ltd.2020-04-30
Humeral Cup Stability & Humeral Cup 135/145o Stability (K193394)Fx Shoulder USA, Inc.2020-04-29
M-Vizion Femoral Revision System Extension (K191816)Medacta International S.A.2020-04-29
Exactech® Equinoxe® Stemless Humeral Components (K192097)Exactech, Inc.2020-04-29
Hive™ Stand-alone Anterior Lumbar Interbody System (K200541)Hd Lifesciences, LLC2020-04-28
Solstice CCI (K200896)Life Spine, Inc.2020-04-28
Affixus(R) Natural Nail(R) System Humeral Nail (K200814)Zimmer GmbH2020-04-28
Tiger® Occipital-Cervical-Thoracic Spinal Fixation System (K200863)Corelink, LLC2020-04-28
PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar (K200007)Microport Orthopedics, Inc.2020-04-25
Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks (K200826)Smith & Nephew, Inc.2020-04-24
SPIRA-C Integrated Fixation System (K193153)Camber Spine Technologies2020-04-24
EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System (K200245)Medos International Sàrl2020-04-24
SeaSpine Reef TH System (K193636)SeaSpine Orthopedics Corporation2020-04-24
Stryker Xia 3 Power Adaptor (K200666)Stryker Spine2020-04-23
CoLink Cfx Plating System (K200762)In2bones USA, LLC2020-04-23
DynaClip Bone Staple (K193305)MedShape, Inc.2020-04-23
ARx Spinal System (K200070)Life Spine, Inc.2020-04-23
DB-Orthopedics (K200752)Dimensional Bioceramics, LLC2020-04-22
EL CAPITAN Anterior Lumber Interbody System (K192492)Astura Medical, LLC2020-04-21
Galileo Vertebral Body Replacement Device (K192145)Bright Spine2020-04-21
MOTO PFJ System (K200122)Medacta International S.A.2020-04-20
S4 Screw System (K191995)Subchondral Solutions, Inc.2020-04-18
SI-Restore Sacroiliac Joint Fixation System (K200868)Biofusion Medical2020-04-17
Kyocera Bipolar Hip System (K200709)Kyocera Medical Technologies, Inc.2020-04-17
ProLift Lateral Fixated (K200338)Life Spine, Inc.2020-04-17
HydroCision SpineJet System (K200729)Hydrocision, Inc.2020-04-16
SIGMA High Performance (HP) Partial Knee System (K193549)Depuy Ireland UC2020-04-16
Comprehensive® Reverse Shoulder (K193373)Biomet, Inc.2020-04-15
Tritanium® X TL Expandable Curved Posterior Lumbar Cage (K200613)Stryker Corporation2020-04-15
COMET Lumbar Interbody Fusion Cage (K191353)Baui Biotech Co., Ltd.2020-04-14
Orthopedic Fixation Pin (K191803)Tinavi (Anhui) Medical Technologies Co., Ltd.2020-04-14
Zimmer Hip Joint Replacement (K200112)Zimmer GmbH2020-04-10
ATLAS Plating System (K191867)MiRus, LLC2020-04-09
CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System (K200052)Orthofix, Inc.2020-04-09
The Optimotion Blue Total Knee System (K191084)Optimotion Implants, LLC2020-04-07
VERTICALE® Cervical System (K192013)Silony Medical GmbH2020-04-07
Origin™ Anterior Cervical Plate System (K193494)Orthopaedic & Spine Development2020-04-06
Tryptik Ti (K200312)Spineart2020-04-06
Akros Scruture Anchor LisFranc Repair Kit (K200361)Akros Medical2020-04-06
FIREBIRD SI Fusion System (K200696)Orthofix, Inc.2020-04-02
EVOS Lumbar Interbody System (K200552)Cutting Edge Spine, LLC2020-04-02
SIRION Lateral Lumbar Interbody System (K192006)Astura Medical, LLC2020-04-02
SYMPHONY™ OCT System (K192646)Medos International SARL2020-04-02
The Gecko Spinal System (K200281)Ortho Development Corporation2020-03-31
Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System (K192818)Stryker Corporation2020-03-31
SI-BONE iFuse Implant System® (K193524)SI-BONE, Inc.2020-03-31
NuVasive Cohere Thoracolumbar Interbody System (K193541)Nu Vasive, Incorporated2020-03-30
Agilon Strip (K193487)Biogennix, LLC2020-03-30
GEO 1st MTP Joint Arthrodesis Plating System (K200108)Gramercy Extremity Orthopedics, LLC2020-03-26
Bonecam Suture Anchor (K193108)Valeris Medical, Inc.2020-03-26
APTUS® Ankle Trauma System 2.8/3.5 (K193633)Medartis AG2020-03-26
APTUS® Foot 2.8-3.5 System (K193639)Medartis AG2020-03-26
FINE Osteotomy around the knee (K193614)Bodycad Laboratories, Inc.2020-03-25
NuVasive 3DP Interfixated ALIF System (K193593)Nu Vasive, Incorporated2020-03-25
NorthStar™ OCT Spinal System (K193615)SeaSpine Orthopedics Corporation2020-03-25
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