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
1489–1512 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 03, 2023
APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line...
K232251 · HWC
Medartis AG
Orthopedic · 98d
Cleared Nov 03, 2023
TRAX® CR Total Knee System
K230078 · JWH
Amplitude
Orthopedic · 297d
Cleared Nov 02, 2023
Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor
K232725 · MBI
Suzhou Endophix Co., Ltd.
Orthopedic · 57d
Cleared Nov 02, 2023
ATEC Posterior Navigated Disc Prep Instruments
K232345 · OLO
Alphatec Spine, Inc.
Orthopedic · 90d
Cleared Nov 02, 2023
STELLAR Knee
K232176 · SBF
Polarisar, Inc.
Orthopedic · 104d
Cleared Nov 01, 2023
OptiMesh Multiplanar Expandable Interbody Fusion System
K230927 · OQB
Spineology, Inc.
Orthopedic · 212d
Cleared Oct 31, 2023
VICTORY™ Lumbar Plate System
K232318 · KWQ
Globus Medical, Inc.
Orthopedic · 89d
Cleared Oct 31, 2023
EVOLUTION® Cement Keel
K231947 · JWH
Microport Orthopedics, Inc.
Orthopedic · 123d
Cleared Oct 31, 2023
Tornier Humeral Nail and Tornier Long Humeral Nail
K230352 · HSB
Tornier, Inc.
Orthopedic · 264d
Cleared Oct 30, 2023
ClariVy™ Cervical IBF System
K231836 · ODP
Vy Spine, LLC
Orthopedic · 130d
Cleared Oct 30, 2023
Renova Spine Balloon Catheter
K231340 · NDN
Biopsybell S.R.L.
Orthopedic · 174d
Cleared Oct 29, 2023
NextAR™ TSA Platform
K232280 · SBF
Medacta International S.A.
Orthopedic · 90d
Cleared Oct 27, 2023
SOLACE Sacroiliac Fixation System
K233241 · OUR
Ht Medical, LLC Dba Xenix Medical
Orthopedic · 29d
Cleared Oct 27, 2023
OR3O Dual Mobility Liners
K232667 · LPH
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared Oct 27, 2023
RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System
K232348 · OVE
MiRus, LLC
Orthopedic · 81d
Cleared Oct 27, 2023
CoreLink Robotic Navigation Instruments
K231494 · OLO
Corelink, LLC
Orthopedic · 157d
Cleared Oct 26, 2023
PressON Spinal Fixation System
K233234 · NKB
Nexus Spine, LLC
Orthopedic · 28d
Cleared Oct 26, 2023
OGmend® Implant Enhancement System
K233223 · QVI
Woven Orthopedic Technologies
Orthopedic · 28d
Cleared Oct 26, 2023
ANAX™ 5.5 Spinal System
K231737 · NKB
Innosys Co., Ltd.
Orthopedic · 134d
Cleared Oct 25, 2023
Balanced Knee® System TriMax PS Plus Tibial Insert
K233093 · JWH
Ortho Development Corporation
Orthopedic · 29d
Cleared Oct 25, 2023
PERLA® TL Posterior Thoraco-lumbar Fixation System
K231069 · NKB
Spineart SA
Orthopedic · 194d
Cleared Oct 25, 2023
Newclip Patient-matched instrumentation non sterile PSI
K221615 · PBF
Newclip Technics
Orthopedic · 509d
Cleared Oct 24, 2023
Knotilus+ PEEK Knotless Anchor
K232683 · MBI
Stryker Endoscopy
Orthopedic · 53d
Cleared Oct 24, 2023
Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System
K232586 · NKB
K&J Consulting Corp.
Orthopedic · 60d