FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
5521–5544 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 16, 2016
COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)
K152754 · PHX
Biomet Manufacturing Corp
Orthopedic · 235d
Cleared May 13, 2016
ALTA Anterior Cervical Interbody Spacer
K160154 · ODP
Astura Medical
Orthopedic · 114d
Cleared May 11, 2016
Catalyst CSR Shoulder System
K152825 · KWT
Catalyst Orthoscience, LLC
Orthopedic · 225d
Cleared May 10, 2016
FiberTak DR
K160319 · MBI
Arthrex, Inc.
Orthopedic · 95d
Cleared May 10, 2016
Vanguard XP Knee System
K153657 · MBH
Biomet, Inc.
Orthopedic · 141d
Cleared May 09, 2016
LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System...
K152431 · KRO
Waldemar Link GmbH & Co. KG
Orthopedic · 257d
Cleared May 06, 2016
NeoFuse HA Enhanced PLIF/TLIF
K153615 · MAX
Ht Medical, LLC
Orthopedic · 141d
Cleared May 06, 2016
INVISION Total Ankle Revision System
K153008 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 205d
Cleared May 05, 2016
Certex Spinal Fixation System
K160428 · NKG
X-Spine Systems, Inc.
Orthopedic · 79d
Cleared May 05, 2016
Cervical Interbody Fusion System
K160324 · ODP
Evolution Spine, LLC
Orthopedic · 90d
Cleared May 05, 2016
Flip Button Suture Anchor
K153585 · MBI
First Ray, LLC
Orthopedic · 141d
Cleared May 05, 2016
HC Spinal System
K151362 · MNH
Hung Chun Bio-S Co., Ltd.
Orthopedic · 350d
Cleared May 04, 2016
Xenco Medical Pedicle Screw System
K160986 · NKB
Xenco Medical, LLC
Orthopedic · 26d
Cleared May 04, 2016
Precision Spine Interspinous Plate System
K160568 · PEK
Precision Spine, Inc.
Orthopedic · 65d
Cleared May 04, 2016
SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF
K153783 · MAX
Spinevision S.A.
Orthopedic · 125d
Cleared May 03, 2016
STROPP (Single Tunnel Repair of Plantar Plate)
K160118 · MBI
Crossroads Extremity Systems, LLC
Orthopedic · 105d
Cleared May 03, 2016
ENZA Zero-Profile Anterior Interbody Fusion
K153720 · OVD
Camber Spine Technologies
Orthopedic · 127d
Cleared Apr 29, 2016
MC-Subtalar(TM) II
K160548 · HWC
Merete Medical GmbH
Orthopedic · 60d
Cleared Apr 29, 2016
OsteoBullet Compression Screw
K160304 · HWC
Phalanx Innovations
Orthopedic · 85d
Cleared Apr 29, 2016
Alphatec Navigation Instruments
K153603 · OLO
Alphatec Spine, Inc.
Orthopedic · 134d
Cleared Apr 29, 2016
REVIVAL(TM) Modular Revision Hip Stem
K152903 · LZO
Corin USA
Orthopedic · 211d
Cleared Apr 29, 2016
Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with...
K152084 · LPH
Corentec Co., Ltd.
Orthopedic · 277d
Cleared Apr 27, 2016
Pyrenees Cervical Plate System
K153526 · KWQ
K2m
Orthopedic · 140d
Cleared Apr 27, 2016
Syzygy Stabilization System
K153152 · NKB
Amendia, Inc.
Orthopedic · 177d