Atlas FDA

Orthopedic

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

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RecordFirmDate
Additional VIPER PRIME™ screws with fenestrations (K171570)Medos International SARL2017-08-31
MAGEC® System (K171791)Nuvasive Specialized Orthopedics, Incorporated2017-08-31
LigaPASS (K172021)Medicrea International SA2017-08-30
Refobacin Bone Cement R (K171540)Biomet, Inc.2017-08-30
CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver (K171592)Conmed Corporation2017-08-29
Altus Spine Titanium Interbody Fusion System (K171329)Altus Partners, LLC2017-08-29
PROCOTYL® PRIME E-CLASS™ XLPE Liner (K171181)Microport Orthopedics, Inc.2017-08-28
2 Hole Lateral Plating System (K172131)Life Spine, Inc.2017-08-28
IRIX-A Lumbar Integrated Fusion System (K171567)X-Spine Systems, Inc.2017-08-28
Locking Cage, Full XPE Cup (K163441)United Orthopedic Corporation2017-08-25
Entrada™ hip stem (K171249)Ortho Development Corporation2017-08-24
MagnetOs Putty (K171563)Kuros Biosciences B.V2017-08-24
PRECICE UNYTE System (K172061)Nuvasive Specialized Orthopedics, Inc.2017-08-24
Fixone Biocomposite Anchor (K171299)Aju Pharm Co., Ltd.2017-08-24
OrthoPediatrics Titanium PediPlates® System (K171173)OrthoPediatrics Corp.2017-08-24
Stryker Self-Punching ICONIX (K171465)Stryker2017-08-24
Ozark(tm) Cervical Plate System (K172104)K2m, Inc.2017-08-23
EVOS Small Fragment Plating System (K172262)Smith & Nephew, Inc.2017-08-23
Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters (K172214)G-21 S.R.L.2017-08-23
Matrixx System (K171140)Nexxt Spine, LLC2017-08-22
Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation System (K172107)Spineology, Inc.2017-08-21
INFINITY™ OCT System (K163375)Medtronic Sofamor Danek USA, Inc.2017-08-21
Zenius™, lliad™ and Kora™ Spinal Fixation Systems (K171526)Medyssey USA, Inc.2017-08-21
Streamline OCT Occipito-Cervico-Thoracic System (K172139)Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2017-08-18
Connector System (K172194)Orthofix, Inc.2017-08-18
ExsoMed ArcPhix and ExsoMed ArrowPhix (K171407)Exsomed Holding Company, LLC2017-08-18
3DMetal Tibial Cones (K170149)Medacta International S.A.2017-08-18
Duo Lumbar Interbody Fusion Device (K171660)Spineology, Inc.2017-08-18
Medline UNITE® Snap-Off Screws (K170782)Medline Industries, Inc.2017-08-18
Q-Fix Suture Anchor (K172165)ArthroCare Corporation2017-08-17
ARIX Ankle Fibula Hook Plate System (K170979)Jeil Medical Corporation2017-08-17
OMNI Anseris Hip Stem (K171156)Omnilife Science2017-08-17
CapSure® PS System (K172175)Spine Wave, Inc.2017-08-16
Medacta Anatomic Shoulder Prosthesis (K170910)Medacta International S.A.2017-08-16
PROPHECY INVISION Pre-operative Navigation System (K170968)Wrightmedicaltechnologyinc2017-08-16
ARIX Foot System (2.3/2.8) (K170780)Jeil Medical Corporation2017-08-14
TalarLift STS (K170624)Fusion Orthopedics, LLC2017-08-11
ShurFit 2C Lumbar Interbody Fusion System (K171657)Precision Spine, Inc.2017-08-11
Paonan Armstrong Posterior Spinal Fixation System (K161225)Paonan Biotech Co., Ltd.2017-08-11
NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System (K163625)Signature Orthopaedics Pty, Ltd.2017-08-11
Zimmer Natural Nail System (K172114)Zimmer, Inc.2017-08-10
CKS Plus Knee System (K163167)Consensus Orthopedics, Inc.2017-08-09
Renovis S141 Lumbar Interbody Fusion System (K170888)Renovis Surgical Technologies2017-08-08
MiniMAX (K170845)Medacta International S.A.2017-08-08
EVOLUTION Revision CCK System (K171389)Microport Orthopedics, Inc.2017-08-08
YUKON OCT Spinal System (K171444)K2m, Inc.2017-08-08
JAZZ Passer Band (K171881)Implanet, S.A.2017-08-08
Anterior Spine Truss System (STS) Interbody Fusion Device (K170851)4Web, Inc.2017-08-07
FuzeFix Screw System (K170038)Fusion Orthopedics, LLC2017-08-07
Premier (K170861)Shandong Weigao Orthopaedic Device Co., Ltd.2017-08-04
The TiBow Expandable Spacer System (K170919)Life Spine, Inc.2017-08-03
Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems (K171456)Choicespine2017-08-03
Arzzt 3.5 / 4.5 Small & Large Fragments System (K162507)Truemed Group, LLC2017-08-03
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System (K171595)Medacta International S.A.2017-08-02
M.U.S.T. MINI Posterior Cervical Screws System (K171369)Medacta International S.A.2017-08-01
M.U.S.T. Combined Set Screws (K171758)Medacta International S.A.2017-08-01
Calix-C Cervical Interbody Spacer (K171075)X-Spine Systems, Inc.2017-08-01
Biomet Knee Joint Replacement Prostheses (K171054)Biomet, Inc.2017-07-28
ARIX Ankle Distal Tibia System (K170313)Jeil Medical Corporation2017-07-27
LumFuse-TP (K171630)Precifit Medical, Ltd.2017-07-25
ANCHORMAN Tibial Ligament Fixation Device (K170388)Summit Medical , Ltd.2017-07-25
True Spinal Fixation System (K171559)Innovative Surgical Designs, Inc.2017-07-24
DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Takú Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates (K163486)Hnm Total Recon, LLC2017-07-24
Klassic HD® Hip System (K171962)Total Joint Othopedics, Inc.2017-07-24
Rampart L Lumbar Interbody Fusion Device (K171724)Spineology, Inc.2017-07-24
ARIX Diaphysis System (K171285)Jeil Medical Corporation2017-07-24
JAWS(TM) Nitinol Staple System (K170923)Paragon 282017-07-24
SIGN IM Nail (K163589)Sign Fracture Care International2017-07-20
dynaMX Intramedullary Implant (K170326)Arthrex, Inc.2017-07-20
CONCORDE LIFT (K171425)Medos International SARL2017-07-20
EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System (K171439)Medos International SARL2017-07-20
TiLock2 Spinal System (K171838)Genesys Spine2017-07-19
U2 Femoral Head (K162957)United Orthopedic Corporation2017-07-17
Genius Total Knee System (K170613)Signature Orthopaedics Pty, Ltd.2017-07-17
HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System (K171413)Globus Medical, Inc.2017-07-14
In2Bones Fracture and Correction System (K170518)In2bones USA, LLC2017-07-14
True Spinal Fixation System (K170710)Innovative Surgical Designs, Inc.2017-07-14
Vitality® Spinal Fixation System (K171907)Zimmer Biomet Spine, Inc.2017-07-14
Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System (K162153)Ascension Orthopedics2017-07-14
Unity Total Knee System (K170808)Corin U.S.A. Limited2017-07-13
Axis Charcot Fixation System, 4.5 to 8.5mm Screw System (K171018)Extremity Medical, LLC2017-07-13
Velofix(tm) Interbody Fusion System (K171749)U&I Corporation2017-07-13
Coveris Cervical Cage System (K170550)Camber Spine Technologies2017-07-13
HD Lumbar Interbody System (K170676)Hd Lifesciences, LLC2017-07-13
OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System (K171813)L&K BIOMED Co., Ltd.2017-07-13
Genesys Spine Apache Interbody Fusion System (K171656)Genesys Spine2017-07-13
NeoFuse Ti3D PLIF/TLIF/Cervical Interbody (K170318)Ht Medical, LLC2017-07-12
EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages (K170503)Eit Emerging Implant Technologies GmbH2017-07-11
SeaSpine Cambria System (K171046)SeaSpine Orthopedics Corporation2017-07-07
Hammertoe Correction System (K171448)Life Spine, Inc.2017-07-07
Endoskeleton TO Interbody Fusion Device (IBD) (K170399)Titan Spine, LLC2017-07-06
CRESCENT™ Spinal System (K171031)Medtronic Sofamor Danek2017-07-06
Spider Cervical Plating System (K170224)X-Spine Systems, Inc.2017-07-06
Gemini-C Hybrid Cervical Interbody System (K170844)Osseus Fusion Systems, LLC2017-07-03
DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless S (K160553)Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.2017-06-30
GRAVITY™ Syndesmosis LP (K170249)Wrightmedicaltechnologyinc2017-06-30
FIBERGRAFT BG Matrix Bone Graft Substitute (K171284)Prosidyan, Inc.2017-06-30
SMR Hybrid Glenoid System (K163397)Lima Corporate S.P.A.2017-06-29
SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL (K161710)Spinal Analytics & Geometrical Impant Co, LLC2017-06-29
PHA S1 Spinal System (K163011)Phamedica, Inc.2017-06-29
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