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
409–432 of 17,899
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 24, 2025
CD Horizon™ Spinal System
K253335 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 24d
Cleared Oct 24, 2025
Infinity™ OCT System
K253129 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Oct 24, 2025
Fule Spinal Fixation System
K252730 · NKB
Beijing Fule Science & Technology...
Orthopedic · 57d
Cleared Oct 24, 2025
Triathlon® Total Knee System - Triathlon® Gold Femoral Components
K252044 · MBH
Howmedica Osteonics Corp., Dba...
Orthopedic · 116d
Cleared Oct 22, 2025
FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone...
K253147 · MQV
Prosidyan, Inc.
Orthopedic · 27d
Cleared Oct 22, 2025
Pre-Sutured Tendon
K253145 · GAT
Rti Surgical, Inc.
Orthopedic · 27d
Cleared Oct 22, 2025
Freedom® Total Knee System – Titan PCK Components
K253144 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 27d
Cleared Oct 22, 2025
SIros-X System
K252322 · OUR
Genesys Spine
Orthopedic · 89d
Cleared Oct 21, 2025
TriALTIS™ Spine System
K253249 · NKB
Medos International SARL
Orthopedic · 22d
Cleared Oct 21, 2025
Aevumed FASE Suture Anchor
K253040 · MBI
Aevumed, Inc.
Orthopedic · 29d
Cleared Oct 21, 2025
OLYMPIC Posterior Spinal Fixation System
K252346 · NKB
Astura Medical
Orthopedic · 85d
Cleared Oct 21, 2025
Fine TTO™
K250394 · PBF
Bodycad Laboratories, Inc.
Orthopedic · 251d
Cleared Oct 20, 2025
A8 INTEGR8™ Porous Pedicle Screws
K242827 · NKB
Allumin8, Inc.
Orthopedic · 397d
Cleared Oct 17, 2025
Osteotomy Wedge System
K252254 · PLF
Sinaptic Surgical
Orthopedic · 88d
Cleared Oct 17, 2025
StealthStation S8 Spine Software
K251282 · OLO
Medtronic Navigation, Inc.
Orthopedic · 176d
Cleared Oct 17, 2025
Estremo Fibular Nail
K250197 · HSB
Citieffe S.R.L.
Orthopedic · 267d
Cleared Oct 16, 2025
FFX Facet Fixation System
K252153 · MRW
Sc Medica
Orthopedic · 99d
Cleared Oct 15, 2025
BioBrace® Extra-Articular Ligament Augmentation Kit
K252946 · MAI
Conmed Corporation
Orthopedic · 30d
Cleared Oct 15, 2025
ELEOS™ Limb Salvage System with NanoCept® Technology
K252920 · QZZ
Onkos Surgical, Inc.
Orthopedic · 33d
Cleared Oct 15, 2025
TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly
K252020 · HRX
Hand Biomechanics Lab, Inc.
Orthopedic · 107d
Cleared Oct 14, 2025
PressON Spinal Fixation System
K253331 · NKB
Nexus Spine
Orthopedic · 14d
Cleared Oct 14, 2025
Mini Superhawk Suture Anchor System
K253010 · MBI
Responsive Arthroscopy, LLC
Orthopedic · 25d
Cleared Oct 13, 2025
Mg OSTEOINJECT™
K251522 · MQV
Bone Solutions, Inc.
Orthopedic · 150d
Cleared Oct 10, 2025
DeGen Medical Latitude-C AM Cervical Interbody Fusion System
K252737 · ODP
Degen Medical
Orthopedic · 43d