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
3913–3936 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 17, 2019
Arthrex SwiveLock Anchors
K190728 · MBI
Arthrex, Inc.
Orthopedic · 27d
Cleared Apr 17, 2019
Arthrex 2.5 mm Tenodesis Screw
K183395 · HWC
Arthrex, Inc.
Orthopedic · 131d
Cleared Apr 12, 2019
MIS Bunion Plating System
K190658 · HRS
Crossroads Extremity Systems, LLC
Orthopedic · 29d
Cleared Apr 12, 2019
Baby Gorilla/Gorilla Plating System
K190365 · HRS
Paragon 28, Inc.
Orthopedic · 56d
Cleared Apr 11, 2019
Zavation Spinal System
K190317 · NKB
Zavation Medical Products, LLC
Orthopedic · 57d
Cleared Apr 11, 2019
Syntec Femoral Nail System
K181296 · HSB
Syntec Scientific Corporation
Orthopedic · 330d
Cleared Apr 10, 2019
M.U.S.T. MINI Posterior Cervical Screws System
K190631 · NKG
Medacta International S.A.
Orthopedic · 29d
Cleared Apr 09, 2019
ExcelsiusGPS
K190653 · OLO
Globus Medical, Inc.
Orthopedic · 26d
Cleared Apr 08, 2019
OIC External Fixation System
K183682 · KTT
Orthopaedic Implant Company
Orthopedic · 101d
Cleared Apr 08, 2019
Vitality® Spinal Fixation System
K183550 · NKB
Zimmer Biomet Spine, Inc.
Orthopedic · 109d
Cleared Apr 08, 2019
CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS®
K182375 · NKB
Globus Medical, Inc.
Orthopedic · 220d
Cleared Apr 06, 2019
MEDINAUT Plus
K182287 · HRX
Imedicom Co., Ltd.
Orthopedic · 226d
Cleared Apr 05, 2019
CROSSWAY Spinal Access System
K190598 · HRX
Globus Medical, Inc.
Orthopedic · 29d
Cleared Apr 04, 2019
PYRAMESH™ Implant System
K183197 · MQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 136d
Cleared Apr 04, 2019
VERTEX Nitinol Staple System
K182943 · JDR
Nvision Biomedical Technologies, LLC
Orthopedic · 163d
Cleared Apr 03, 2019
Monster® Screw System
K190586 · HWC
Paragon 28, Inc.
Orthopedic · 28d
Cleared Apr 03, 2019
Karma® Fixation System
K190289 · OWI
Spinal Elements, Inc.
Orthopedic · 51d
Cleared Apr 03, 2019
iFuse Implant System®
K190230 · OUR
SI-BONE, Inc.
Orthopedic · 56d
Cleared Apr 03, 2019
FlareHawk Interbody Fusion System
K183184 · MAX
Integrity Implants, Inc.
Orthopedic · 135d
Cleared Apr 03, 2019
LINK GEMINI SL Total Knee System
K182872 · JWH
Waldemar Link GmbH & Co. KG
Orthopedic · 173d
Cleared Apr 03, 2019
CONCORDE LIFT
K182349 · MAX
Medos International SARL
Orthopedic · 217d
Cleared Apr 02, 2019
Zimmer Biomet Ceramic Heads
K181171 · LZO
Zimmer, Inc.
Orthopedic · 335d
Cleared Apr 01, 2019
Vantage Total Ankle Flat Cut Talar Components
K183343 · HSN
Exactech, Inc.
Orthopedic · 119d
Cleared Apr 01, 2019
Bencox Mirabo Cup Multi Hole
K182221 · LPH
Corentec Co., Ltd.
Orthopedic · 228d