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
5953–5976 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 20, 2015
inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical...
K143626 · KWQ
Zimmer Spine, Inc.
Orthopedic · 88d
Cleared Mar 20, 2015
LnK Anterior Cervical Plate System
K143279 · KWQ
L & K Biomed Co., Ltd.
Orthopedic · 126d
Cleared Mar 20, 2015
Xenco Medical Lumbar Interbody System
K143158 · MAX
Xenco Medical, LLC
Orthopedic · 137d
Cleared Mar 20, 2015
ARROW Reverse Shoulder long keel and short keel glenoid base
K142778 · PHX
Fournitures Hospitalieres Industrie
Orthopedic · 175d
Cleared Mar 20, 2015
F1-Modular Pedicle Screw System
K142531 · NKB
Degen Medical
Orthopedic · 192d
Cleared Mar 20, 2015
PROXIMAL HUMERUS PLATING SYSTEM
K141493 · HRS
Miami Device Solutions
Orthopedic · 288d
Cleared Mar 19, 2015
Treace Medical Concepts(TMC) Plating System
K143717 · HRS
Treace Medical Concepts, Inc.
Orthopedic · 80d
Cleared Mar 17, 2015
Evolve UniPolar Head
K143184 · KWL
Signature Orthopaedics Pty, Ltd.
Orthopedic · 132d
Cleared Mar 16, 2015
Nautilus Spinal System
K150390 · NKB
Life Spine, Inc.
Orthopedic · 26d
Cleared Mar 13, 2015
NuVasive CoRoent System
K141665 · MAX
Nuvasive, Inc.
Orthopedic · 263d
Cleared Mar 12, 2015
Biomet Spine Fusion System
K142634 · MAX
Biomet Spine, LLC
Orthopedic · 176d
Cleared Mar 10, 2015
RESTORIS Multicompartmental Knee System
K150307 · NPJ
Mako Surgical Corp.
Orthopedic · 29d
Cleared Mar 06, 2015
InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV...
K150322 · NDN
Pan Medical , Ltd.
Orthopedic · 25d
Cleared Mar 05, 2015
Leva(TM) Spacer System
K150285 · MAX
Spine Wave, Inc.
Orthopedic · 28d
Cleared Mar 05, 2015
AccuLIF TL and PL Cage
K143616 · MAX
Stryker Corporation
Orthopedic · 76d
Cleared Mar 05, 2015
Affix IIS Spinous Process Plate System
K143388 · PEK
Nu Vasive, Incorporated
Orthopedic · 99d
Cleared Mar 05, 2015
NP Cement HV
K143134 · LOD
Cossington, Ltd.
Orthopedic · 125d
Cleared Mar 05, 2015
NP Cement HV Genta
K143100 · LOD
Cossington, Ltd.
Orthopedic · 128d
Cleared Mar 05, 2015
INFINITY (TM) TOTAL ANKLE SYSTEM
K141740 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 251d
Cleared Mar 04, 2015
Extremity Medical Calcaneal Osteotomy Device
K150309 · HWC
Extremity Medical, LLC
Orthopedic · 23d
Cleared Mar 04, 2015
SALVATION External Fixation System
K150004 · KTT
Wrightmedicaltechnologyinc
Orthopedic · 61d
Cleared Mar 04, 2015
Consensus Knee System Modular Tibial Baseplate
K143725 · JWH
Consensus Orthopedics, Inc.
Orthopedic · 65d
Cleared Mar 04, 2015
Simpliciti Shoulder System
K143552 · PKC
Tornier, Inc.
Orthopedic · 79d
Cleared Mar 04, 2015
Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS
K143331 · HRS
Zimmer, Inc.
Orthopedic · 104d