Atlas FDA

Orthopedic

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

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RecordFirmDate
Stryker CrossFlow Integrated Arthroscopy Pump (K191259)Stryker Corp.2019-07-12
Nuvis Battery Arthroscope (K191594)Integrated Endoscopy, Inc.2019-07-11
Voyant System (K191579)Viseon, Inc.2019-07-11
Velofix TLIF Cage (K183243)U&I Corporation2019-07-10
Salvo™ Spine System (K191045)Spine Wave, Inc.2019-07-10
Nexxt Matrixx System (K191408)Nexxt Spine, LLC2019-07-10
Materialise Glenoid Positioning System (K190286)Materialise NV2019-07-08
OrthoPediatrics Cannulated Screw System (K190324)OrthoPediatrics Corp.2019-07-05
Zimmer Guide Wire Devices (K191238)Zimmer, Inc.2019-07-05
Harrier-SA Lumbar Interbody System (K191367)Choice Spine, LLC2019-07-05
Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System (K190498)Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.2019-07-05
NuVasive® Camber Laminoplasty System (K191169)Nu Vasive, Incorporated2019-07-03
OsteoFab Suture Anchors (K190915)Oxford Performance Materials, Inc.2019-07-03
Infinity Fixation System (K191204)Conmed Corporation2019-07-03
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology (K190959)Medtronic Sofamor Danek USA, Inc.2019-07-03
TriMed Nitinol Staple System (K190166)TriMed, Inc.2019-07-01
TxTi IBF System (K183064)Innovasis, Inc.2019-06-28
MicroLink All-Suture Button Fixation System (Radiopaque) (K190582)Conmed Corporation2019-06-28
MicroLink All-Suture Button Fixation System (Radiolucent) (K190516)Conmed Corporation2019-06-28
HEALIX ADVANCE Anchor with DYNA+TAPE Sutures (K191483)Medos International SARL2019-06-28
WishBone Guided Growth System (K182704)Wishbone Medical2019-06-25
Orthoss(R) (K190754)Geistlich Pharma AG2019-06-23
AXTi Titanium Stand-Alone ALIF System (K182139)Innovasis, Inc.2019-06-21
DePuy Synthes Plates and Screws Portfolio (K190750)DePuy Synthes2019-06-21
LineSider™ Spinal System (K190360)Integrity Implants, Inc.2019-06-21
Renovis A200 PS Knee System as part of the Renovis A200 Knee System (K190122)Renovis Surgical Technologies2019-06-20
PK High Tibial Osteotomy Correction System (K182285)Paonan Biotech Co., Ltd.2019-06-20
VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 (K190545)Icotec AG2019-06-20
The JASPER Spinal Fixation System II (K190762)Gbs Commonwealth Co., Ltd.2019-06-19
Republic Spine Restore Cervical Interbody Fusion System (K190889)Republic Spine, LLC2019-06-19
LOQTEQ VA Foot Plates 2.5 (K182785)Aap Implantate AG2019-06-19
LxHA PEEK Lateral IBF System (K190684)Innovasis, Inc.2019-06-17
AEQUALIS FLEX REVIVE Shoulder System (K191318)Tornier, Inc.2019-06-14
Treace Medical Concepts (TMC) Snap-Off Screw System (K183363)Treace Medical Concepts, Inc.2019-06-13
Oyster ACIF Cage (K182608)Silony Medical GmbH2019-06-13
ProLift® Expandable System (K191005)Life Spine, Inc.2019-06-13
Lateral Plate System (K190016)Corelink, LLC2019-06-12
Aequalis Ascend Flex Shoulder System (K190521)Tornier S.A.S.2019-06-12
T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System (K191271)Stryker Trauma GmbH2019-06-11
NOVA Minimally Invasive System (K182416)Baui Biotech Co., Ltd.2019-06-11
Arthrex SwiveLock Suture Anchor (K191226)Arthrex, Inc.2019-06-11
Arzzt Distal Radius and Ulna System (K182650)Truemed Group, LLC2019-06-10
AccuFill Bone Substitute Material (K190814)Zimmer Knee Creations2019-06-10
Mini Cannulated Headed and Headless Screw Set (K183104)Stryker GmbH2019-06-10
SpaceFlex Knee (K190216)G21, S.R.L.2019-06-09
RIVAL View Plating Systems and Reduce Fracture Plating Systems (K190388)Orthofix Srl2019-06-07
DJO Acetabular System (K190057)Encore Medical L.P.2019-06-07
PROSTEP TBC Implant System (K183620)Wrightmedicaltechnologyinc2019-06-06
RIGEL PEEK Anterior Cervical Interbody Fusion System (K190618)MiRus, LLC2019-06-06
Idys ALIF TiVac (K191263)Clariance, Sas2019-06-06
Corin BiPolar-i (K183114)Corin U.S.A. Limited2019-06-05
Signature ONE System (K190595)Orthosoft Inc (D/B/A Zimmer Cas)2019-06-05
HydroCision TenJet Device (K190804)Hydrocision, Inc.2019-06-05
MectaScrew PEEK Interference Screw (K190892)Medacta International S.A.2019-06-04
Vanguard XP Knee System (K190068)Zimmer, Inc.2019-06-04
Unity Total Knee System (K183533)Corin U.S.A. Limited2019-06-04
Solanas® Posterior OCT Fixation System (K191185)Alphatec Spine2019-06-03
Cannulated Hemi Implant (K190543)Vilex IN Tennessee, Inc.2019-05-31
NEXXT MATRIXX Stand Alone Cervical System (K190546)Nexxt Spine, LLC2019-05-31
PALACOS fast R+G (K190766)Heraeus Medical GmbH2019-05-31
Cervical Plate (K190565)Eisertech, LLC2019-05-31
Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling (K182678)Zimmer, Inc.2019-05-31
MasterLoc Extension (K191145)Medacta International S.A.2019-05-30
Fuji Cervical Plate System (K183084)Altus Partners, LLC2019-05-29
Revolution External Plating System (K181630)New Standard Device Dba Metalogix2019-05-29
Juliet® Ti LL Lumbar Interbody Device (K190877)Spineart2019-05-29
IGNITE Bone Void Filler (K190482)Wrightmedicaltechnologyinc2019-05-28
MectaLock PEEK Suture Anchor (K190474)Medacta International S.A.2019-05-28
AccelFix Spinal Fixation System (K182544)L&K BIOMED Co., Ltd.2019-05-28
InCore® Lapidus Sterile Kits (K190231)Nextremity Solutions, Inc.2019-05-24
MobileLink Acetabular Cup System (K182321)Waldemar Link GmbH & Co. KG2019-05-24
Mariner Outrigger Revision System (K183639)SeaSpine Orthopedics Corporation2019-05-23
Luna 3D GEN2 Interbody Fusion System (K183560)Benvenue Medical, Inc.2019-05-23
SYNMESH System (K183054)Depuy Synthes Spine2019-05-23
Rampart One Lumbar Interbody Fusion System (K191091)Spineology, Inc.2019-05-23
Connector System (K190751)Orthofix, Inc.2019-05-22
IntraLock Lapidus System (K182342)Fusion Orthopedics, LLC2019-05-21
FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire (K190125)T.A.G. Medical Products Corporation, Ltd.2019-05-19
Delta Xtend Reverse Shoulder System (K183077)Depuy(Ireland)2019-05-17
Revolution Radial Head (K183618)Ignite Orthopedics, Inc.2019-05-17
Precision Casting Solutions Total Knee System (K190355)Precision Casting Solutions, Inc.2019-05-16
EVOLUTION NitrX Medial-Pivot Knee (K182251)Mircoport Orthopedics, Inc.2019-05-16
CAYMAN LP Plate System (K190584)K2m, Inc.2019-05-15
ORTHOLOC™ 2 Lapidus with Rotation System (K190670)Wrightmedicaltechnologyinc2019-05-14
SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (K190069)Arrowhead De, LLC2019-05-14
MVP Cervical Plate System (K190170)GS Medical Co., Ltd.2019-05-13
Vanguard Complete Knee System (K183583)Zimmer, Inc.2019-05-10
Delta Dual Mobility System (K181491)Lima Corporate S.P.A.2019-05-09
CYGNUS™ Anterior Cervical Plate System (K190666)MiRus, LLC2019-05-09
UNiD Patient specific 3D printed TLIF cage (K190092)Medicrea International SA2019-05-08
KeYi Spinal Fixation System (K190567)Beijing Keyi Medical Device Technology Co., Ltd.2019-05-08
COLOSSEUM Mesh (K190147)Globus Medical, Inc.2019-05-08
Capstone Control™ Spinal System (K190165)Medtronic Sofamor Danek USA, Inc.2019-05-06
Arthrex DynaNite® PIP (Hammertoe) Implant (K190287)Arthrex, Inc.2019-05-03
HALF DOME Posterior Lumbar Interbody System (K182877)Astura Medical, LLC2019-05-03
Aptis Medical Distal Radio Ulnar Joint Implant (K190599)Aptis Medical, LLC2019-05-03
MatrixRIB Fixation System (K190409)DePuy Synthes2019-05-03
PASS LP Spinal System (K190376)Medicrea International SA2019-05-02
Boomerang™ Anterior Cervical Plate System (K190227)Choicespine, LP2019-05-01
SambaScrew 3D SI Fusion System (K183342)Orthofix, Inc.2019-04-30
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