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
505–528 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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 CT 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
Cleared Oct 10, 2025
TMINI Miniature Robotic System
K252544 · OLO
THINK Surgical, Inc.
Orthopedic · 59d
Cleared Oct 10, 2025
Eleganz IM Threaded Nail System (IM Threaded Nail System)
K252312 · HWC
Dev4
Orthopedic · 78d
Cleared Oct 09, 2025
iFuse Bedrock Granite Implant System
K253094 · OUR
SI-BONE, Inc.
Orthopedic · 16d
Cleared Oct 09, 2025
Pediatric Plating Platform I Small-Mini
K252600 · HRS
OrthoPediatrics Corp.
Orthopedic · 52d
Cleared Oct 08, 2025
MetaFore Small Screw System
K250536 · HWC
Extremity Medical, LLC
Orthopedic · 226d
Cleared Oct 07, 2025
Eminent Spine Posterior SI System
K250894 · OUR
Eminent Spine
Orthopedic · 196d
Cleared Oct 03, 2025
AETOS Shoulder System Stemless Humeral Prosthesis
K252129 · PKC
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Oct 03, 2025
xvision Spine system
K251639 · SBF
Augmedics, Ltd.
Orthopedic · 127d
Cleared Oct 02, 2025
Cannulated Screw and Kirschner (K wire) System
K252758 · HWC
Orthonovis, Inc.
Orthopedic · 34d
Cleared Oct 01, 2025
Newclip Patient-matched instrumentation non sterile PSI
K250767 · PBF
Newclip Technics
Orthopedic · 202d