FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,899 results
361–384 of 17,899
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 04, 2025
Spineology Navigation Instruments
K251943 · OLO
Spineology, Inc.
Orthopedic · 163d
Cleared Dec 04, 2025
FFX Facet Fixation System
K250679 · MRW
Sc Medica
Orthopedic · 273d
Cleared Dec 01, 2025
Minuteman® G6 MIS Fusion Plate
K253250 · PEK
Spinal Simplicity, LLC
Orthopedic · 63d
Cleared Dec 01, 2025
Equinoxe® Humeral Reconstruction Prosthesis
K250713 · KWT
Exactech, Inc.
Orthopedic · 266d
Cleared Nov 25, 2025
ZSFab Lumbar Interbody System
K252610 · MAX
Zsfab, Inc.
Orthopedic · 99d
Cleared Nov 25, 2025
Medusa Orthopedics Boa External Fixation System
K252555 · KTT
Medusa Orthopedics, LLC
Orthopedic · 104d
Cleared Nov 24, 2025
Dakota LP System
K250769 · ODP
Precision Spine, Inc.
Orthopedic · 256d
Cleared Nov 21, 2025
EffortMed PEEK Cages & Corpectomy Cages
K252686 · ODP
Effortmed, LLC
Orthopedic · 87d
Cleared Nov 21, 2025
Articulator Arthroscopic Bur
K252666 · HRX
Joint Preservation Innovations, LLC
Orthopedic · 88d
Cleared Nov 21, 2025
BEE HA
K250560 · ODP
NGMedical GmbH
Orthopedic · 269d
Cleared Nov 20, 2025
CORUS-LX Implant
K253190 · MRW
Providence Medical Technology, Inc.
Orthopedic · 55d
Cleared Nov 20, 2025
TaperSet™ Hip System
K252846 · LPH
Shalby Advanced Technologies, Inc....
Orthopedic · 73d
Cleared Nov 20, 2025
The Response Ortho Smart Fixator - Hexapod System
K252625 · KTT
Response Ortho Solutions, LLC
Orthopedic · 93d
Cleared Nov 20, 2025
OptumSI Implant System
K251365 · OUR
Si Solutions, LLC
Orthopedic · 203d
Cleared Nov 19, 2025
ATTUNE™ Total Knee System
K253197 · JWH
Depuy Ireland UC
Orthopedic · 54d
Cleared Nov 19, 2025
SternaFuse Ti Fixation System
K252661 · HRS
Fusion Innovations, LLC
Orthopedic · 89d
Cleared Nov 19, 2025
MyPAO SA guides
K242603 · PBF
Medacta International S.A.
Orthopedic · 446d
Cleared Nov 18, 2025
ToeJack MIS Bunion System
K253423 · HRS
Nvision Biomedical Technologies, Inc.
Orthopedic · 54d
Cleared Nov 18, 2025
Universal Spinal System
K252729 · NKB
Double Medical Technology, Inc.
Orthopedic · 82d
Cleared Nov 14, 2025
KLS Martin IPS Forearm System
K250865 · HRS
KLS-Martin L.P.
Orthopedic · 238d
Cleared Nov 13, 2025
Geminus Volar Distal Radius Plating System
K252949 · HRS
Skeletal Dynamics, Inc.
Orthopedic · 58d
Cleared Nov 13, 2025
Rosa® Knee System
K251314 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 199d
Cleared Nov 12, 2025
WRISTAR MultiAx Distal Radius Kit
K252959 · HRS
Intrauma S.P.A
Orthopedic · 57d
Cleared Nov 12, 2025
CMORE® CT System
K252327 · NKG
Icotec AG
Orthopedic · 110d