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
457–480 of 17,899
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 17, 2025
Ruthless Spine RJB
K252615 · QWL
Ruthless, LLC Dba Ruthless Spine
Orthopedic · 29d
Cleared Sep 15, 2025
SpaceFix Shoulder Spacer
K252443 · MBB
G21, S.R.L.
Orthopedic · 42d
Cleared Sep 15, 2025
iGPS Navigation Instruments
K251780 · OLO
SI-BONE, Inc.
Orthopedic · 97d
Cleared Sep 12, 2025
Spine & Trauma Navigation Instruments
K252562 · OLO
Brainlab AG
Orthopedic · 29d
Cleared Sep 12, 2025
DynaNail TTC Fusion System
K250628 · HSB
MedShape, Inc.
Orthopedic · 193d
Cleared Sep 11, 2025
Mazor X System / Mazor X Stealth Edition
K251316 · OLO
Mazor Robotics , Ltd.
Orthopedic · 135d
Cleared Sep 11, 2025
OsteoProbe (OP-100)
K250216 · QGQ
Active Life Scientific, Inc.
Orthopedic · 230d
Cleared Sep 10, 2025
OptiVu™ Shoulder
K252530 · SBF
Mr Surgical Solutions, LLC
Orthopedic · 30d
Cleared Sep 09, 2025
Quadsense (Quadsense and Quadsense Pro)
K252524 · ONN
Eventum Orthopaedics, Ltd.
Orthopedic · 29d
Cleared Sep 08, 2025
MAXXOS P.A.C.E. Foot & Ankle Plating System
K251892 · HRS
Maxxos Medical GmbH
Orthopedic · 80d
Cleared Sep 05, 2025
All-Suture Dual Anchor System
K250095 · MBI
Suturetech, Inc.
Orthopedic · 234d
Cleared Sep 04, 2025
NextAR(TM) Shoulder Platform
K251737 · SBF
Medacta International S.A.
Orthopedic · 90d
Cleared Sep 04, 2025
Endoskeleton™ Interbody Systems
K251444 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 118d
Cleared Sep 03, 2025
Kinos Total Ankle System
K252454 · HSN
Restor3d
Orthopedic · 30d
Cleared Sep 03, 2025
IdentiTi™ II ALIF Standalone Interbody System
K251575 · OVD
Alphatec Spine
Orthopedic · 104d
Cleared Sep 02, 2025
Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component
K251975 · NJD
Ignite Orthomotion
Orthopedic · 68d
Cleared Aug 29, 2025
CurvaFix Low Profile System
K252019 · HWC
Curvafix, Inc.
Orthopedic · 60d
Cleared Aug 29, 2025
ArTT Augments and Buttresses and Bone Screws
K251718 · LPH
Lima Corporate S.P.A.
Orthopedic · 86d
Cleared Aug 29, 2025
IVA & AEON Cervical and Lumbar Cage System
K250335 · ODP
K&J Consulting
Orthopedic · 205d
Cleared Aug 28, 2025
JAZZ Spinal System
K252437 · NKB
Implanet
Orthopedic · 27d
Cleared Aug 28, 2025
JARVIS Glenoid Reverse Shoulder Prosthesis
K252411 · PHX
FH Industrie
Orthopedic · 27d
Cleared Aug 28, 2025
Proximity Anterior Cervical Plate System
K251965 · KWQ
Alphatec Spine, Inc.
Orthopedic · 63d
Cleared Aug 27, 2025
Phoenix Sinus Tarsi Stent System
K251382 · HWC
Astra Orthomed, Inc.
Orthopedic · 117d
Cleared Aug 27, 2025
ELID (Endoscopic Less Invasive Decompression) System
K243774 · HRX
Lesspine Innovations
Orthopedic · 264d