FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,766 results
3793–3816 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 06, 2019
SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments,...
K183119 · OUR
Globus Medical, Inc.
Orthopedic · 89d
Cleared Feb 06, 2019
Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion...
K182885 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 114d
Cleared Feb 05, 2019
PRECICE® BONE TRANSPORT™ System
K182170 · HSB
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 179d
Cleared Feb 04, 2019
Velofix Interbody Fusion System
K190067 · ODP
U&I Corporation
Orthopedic · 20d
Cleared Feb 04, 2019
EIT Cellular Titanium Lumbar Cage - T/PLIF
K183447 · MAX
Eit Emerging Implant Technologies GmbH
Orthopedic · 54d
Cleared Feb 01, 2019
SECULOK™ ACP System
K190053 · KWQ
U&I Corporation
Orthopedic · 21d
Cleared Feb 01, 2019
Pedimax II - Pedicular Screw Spinal System
K180626 · NKB
Gm Dos Reis Industria E Comerico Ltda.
Orthopedic · 329d
Cleared Jan 30, 2019
Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid
K183696 · PHX
Tornier, Inc.
Orthopedic · 30d
Cleared Jan 30, 2019
Zimmer Segmental System Proximal Femoral Component
K183136 · LZO
Zimmer, Inc.
Orthopedic · 78d
Cleared Jan 30, 2019
MOTO Partial Knee System
K183029 · HSX
Medacta International S.A.
Orthopedic · 90d
Cleared Jan 29, 2019
AQrate Robotic Assistance System
K182000 · HAW
Globus Medical, Inc.
Orthopedic · 187d
Cleared Jan 29, 2019
Neo Cage System TM
K181048 · MAX
Neo Medical SA
Orthopedic · 285d
Cleared Jan 28, 2019
MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts,...
K183025 · JWH
B-One Ortho, Corp.
Orthopedic · 88d
Cleared Jan 28, 2019
Cervical Spacer
K182477 · ODP
Additive Implants, LLC
Orthopedic · 140d
Cleared Jan 28, 2019
Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow
K181307 · JDC
Zimmer, Inc.
Orthopedic · 256d
Cleared Jan 28, 2019
VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System
K180822 · MAX
Wenzel Spine, Inc.
Orthopedic · 304d
Cleared Jan 25, 2019
Treace Medical Concepts (TMC) Plating System
K183321 · HRS
Treace Medical Concepts, Inc.
Orthopedic · 56d
Cleared Jan 25, 2019
HammerToe Compression System
K183228 · HTY
Paragon 28, Inc.
Orthopedic · 66d
Cleared Jan 25, 2019
SMR Lateralized Connectors with screws
K183042 · KWS
Lima Corporate S.P.A.
Orthopedic · 84d
Cleared Jan 25, 2019
Hoffmann LRF System
K182968 · KTT
Stryker GmbH
Orthopedic · 91d
Cleared Jan 25, 2019
SI-Restore® Sacroiliac Joint Fixation System
K182919 · OUR
Biofusion Medical
Orthopedic · 98d
Cleared Jan 25, 2019
NEST Interbody System
K180230 · MAX
Paonan Biotech Co., Ltd.
Orthopedic · 364d
Cleared Jan 24, 2019
ROSA Knee System
K182964 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 91d
Cleared Jan 22, 2019
Compress and Mini Compress Anti-Rotation Spindles
K183553 · MBF
Biomet, Inc.
Orthopedic · 33d