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
6145–6168 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 05, 2014
Neo Total Knee System
K142388 · JWH
New Era Orthopedics, LLC
Orthopedic · 100d
Cleared Dec 05, 2014
ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT
K142052 · KTT
Orthofix Srl
Orthopedic · 130d
Cleared Dec 04, 2014
ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM
K141632 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 169d
Cleared Dec 02, 2014
GMK EXTENSION
K142069 · JWH
Medacta International
Orthopedic · 125d
Cleared Dec 02, 2014
PGS 5.5 MM CANNULATED PEDICLE SCREW
K141282 · NKB
Pinnacle Spine Group
Orthopedic · 200d
Cleared Dec 01, 2014
CD HORIZON Spinal System
K143141 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Dec 01, 2014
CD HORIZON Spinal System
K142591 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 77d
Cleared Dec 01, 2014
JULIET LL
K141135 · MAX
Spineart
Orthopedic · 214d
Cleared Nov 28, 2014
Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions,...
K143066 · HRS
Zimmer, Inc.
Orthopedic · 35d
Cleared Nov 28, 2014
nva, nvp, nvt
K142594 · MAX
Nvision Biomedical Technologies, LLC
Orthopedic · 74d
Cleared Nov 26, 2014
G3 Active Plate Large Fragment System
K142938 · HRS
Genesis Fracture Care, Inc.
Orthopedic · 48d
Cleared Nov 25, 2014
Univers Rivers Shoulder Prosthesis System
K142863 · PHX
Arthrex, Inc.
Orthopedic · 55d
Cleared Nov 25, 2014
CoRoent Small Interlock System
K142299 · OVE
Nu Vasive, Incorporated
Orthopedic · 99d
Cleared Nov 25, 2014
IN:C2 SPINAL FIXATION SYSTME
K141537 · OVE
Spine Smith Holdings, LLC
Orthopedic · 168d
Cleared Nov 25, 2014
ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
K141333 · ODP
Spinefrontier, Inc.
Orthopedic · 188d
Cleared Nov 24, 2014
Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical...
K142403 · KWS
Zimmer GmbH
Orthopedic · 89d
Cleared Nov 24, 2014
KangLi pedical screw spinal system
K142290 · MNH
Suzhou Kangli Orthopaedics Instrument...
Orthopedic · 98d
Cleared Nov 24, 2014
GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)
K142072 · KWS
Custom Orthopaedic Solutions, Inc.
Orthopedic · 124d
Cleared Nov 24, 2014
OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE
K140716 · MAX
Interventional Spine, Inc.
Orthopedic · 248d
Cleared Nov 21, 2014
VEGA Knee System
K143106 · JWH
Aesculap Implant Systems, LLC
Orthopedic · 23d
Cleared Nov 21, 2014
BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD
K141377 · LZO
Merete Medical GmbH
Orthopedic · 178d
Cleared Nov 20, 2014
PhaLinx Hammertoe System
K142585 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 66d
Cleared Nov 20, 2014
Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software
K142520 · KTT
Smith & Nephew, Inc.
Orthopedic · 73d
Cleared Nov 20, 2014
LUNA INTERBODY SYSTEM
K142023 · MAX
Benvenue Medical, Inc.
Orthopedic · 118d