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
5425–5448 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 29, 2016
VertiForm Posterior Fixation System
K161499 · NKB
Next Orthosurgical
Orthopedic · 58d
Cleared Jul 29, 2016
Cannulated Screw
K161058 · HWC
Miami Device Solutions, LLC
Orthopedic · 105d
Cleared Jul 29, 2016
MEDINAUT Kyphoplasty System
K153296 · NDN
Imedicom Co., Ltd.
Orthopedic · 259d
Cleared Jul 28, 2016
Spinal Elements' Spinous Process Plate System
K160465 · PEK
Spinal Elements, Inc.
Orthopedic · 160d
Cleared Jul 28, 2016
Genesys Spine Apache® Anchored Cervical Interbody Fusion System
K152099 · OVE
Genesys Spine
Orthopedic · 366d
Cleared Jul 27, 2016
Precision Screw
K160385 · OLO
Cryptych Pty, Ltd.
Orthopedic · 167d
Cleared Jul 27, 2016
The Progressive Orthopaedic Total Hip System
K151424 · LPH
The Progressive Orthopaedic Company, LLC
Orthopedic · 426d
Cleared Jul 26, 2016
Conventus Orthopaedics Ulna Fixation System
K161048 · HRS
Conventus Orthopaedics, Inc.
Orthopedic · 103d
Cleared Jul 26, 2016
EasyStep
K160813 · JDR
Stryker GmbH
Orthopedic · 124d
Cleared Jul 22, 2016
K2M Growing Spine System
K161028 · PGM
K2m, Inc.
Orthopedic · 101d
Cleared Jul 21, 2016
Genesys Spine Apache® Lateral Lumbar Interbody Fusion System
K161404 · MAX
Genesys Spine
Orthopedic · 62d
Cleared Jul 21, 2016
EVEREST Spinal System
K161369 · NKB
K2m, Incorporated
Orthopedic · 65d
Cleared Jul 21, 2016
Tritanium® PL Cage
K160955 · MAX
Stryker
Orthopedic · 107d
Cleared Jul 21, 2016
MectaLIF Anterior Stand-Alone
K160605 · OVD
Medacta International
Orthopedic · 141d
Cleared Jul 21, 2016
PathLoc-C Posterior Cervical Fixation System
K153439 · NKG
L & K Biomed Co., Ltd.
Orthopedic · 237d
Cleared Jul 19, 2016
Origin Coxa Vara Hip Stem
K161155 · MEH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 85d
Cleared Jul 19, 2016
DePuy Actis DuoFix Hip Prosthesis
K160907 · MEH
Depuy(Ireland)
Orthopedic · 109d
Cleared Jul 19, 2016
INTRAFIX(TM) Advance Tibial Fastener System
K160804 · MAI
Medos International SARL
Orthopedic · 118d
Cleared Jul 15, 2016
Threshold™ Pedicular Fixation System
K161694 · NKB
Spineology, Inc.
Orthopedic · 25d
Cleared Jul 15, 2016
ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal...
K161668 · JWH
Conformis, Inc.
Orthopedic · 29d
Cleared Jul 15, 2016
Ascential IBD PEEKc Spacer
K161407 · ODP
Stryker Spine
Orthopedic · 56d
Cleared Jul 15, 2016
NuVasive® VersaTie System
K161265 · OWI
Nu Vasive, Incorporated
Orthopedic · 71d
Cleared Jul 15, 2016
TransContinental® M Spacers and InterContinental® Plate-Spacers
K161223 · OVD
Globus Medical, Inc.
Orthopedic · 77d
Cleared Jul 15, 2016
Keos Lumbar IBFD
K160631 · MAX
Keos
Orthopedic · 130d