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
385–408 of 17,899
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 12, 2025
EMPOWR Acetabular® Liner Extension
K251833 · LPH
Encore Medical, L.P.
Orthopedic · 149d
Cleared Nov 10, 2025
Atlas Spine HiRISE™ Expandable Cervical Corpectomy System
K252560 · PLR
Atlas Spine, Inc.
Orthopedic · 89d
Cleared Nov 06, 2025
Catalyst F1x Shoulder System
K252418 · KWS
Catalyst Orthoscience, Inc.
Orthopedic · 97d
Cleared Nov 06, 2025
Ultra™ Compression Screw System
K251555 · HWC
Pace Surgical
Orthopedic · 169d
Cleared Nov 05, 2025
ExcelsiusGPS™ Instruments
K250599 · OLO
Globus Medical, Inc.
Orthopedic · 250d
Cleared Nov 05, 2025
Allure Hip Stem and Intramedullary Plugs
K250375 · MEH
Waldemar Link GmbH & Co. KG
Orthopedic · 268d
Cleared Nov 04, 2025
GMReis Suture Anchors
K252664 · MBI
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 74d
Cleared Nov 04, 2025
MedCAD® AccuStride™ System
K251709 · PBF
Medcad
Orthopedic · 154d
Cleared Nov 03, 2025
Kyphoplasty Balloon Dilatation Catheters
K252458 · HRX
Shanghai Lange Medtech Co., Ltd.
Orthopedic · 90d
Cleared Oct 31, 2025
Freedom Metaphyseal Cone Implants (Metaphyseal Cones)
K252777 · MBH
Maxx Orthopedics, Inc.
Orthopedic · 59d
Cleared Oct 31, 2025
Firebird SI Navigation System
K252088 · OLO
Orthofix US, LLC
Orthopedic · 121d
Cleared Oct 31, 2025
MSS - Humeral reverse liners extension
K250338 · PHX
Medacta International S.A.
Orthopedic · 267d
Cleared Oct 30, 2025
Tornier Humeral Reconstruction System Max (Tornier HRS Max)
K251686 · KWT
Tornier, Inc.
Orthopedic · 150d
Cleared Oct 29, 2025
JARVIS Diaphyseal Stem Standard
K253345 · PHX
FH Industrie
Orthopedic · 29d
Cleared Oct 29, 2025
Freedom Infinia™ Total Knee System
K253314 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 29d
Cleared Oct 29, 2025
AETOS Shoulder System Meta Humeral Prosthesis Size 0
K252416 · KWS
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Oct 29, 2025
Arthrex SutureTak Suture Anchor
K252314 · MBI
Arthrex, Inc.
Orthopedic · 96d
Cleared Oct 29, 2025
Synchfix EVT
K251643 · HTN
Wright Medical Technology, Inc....
Orthopedic · 153d
Cleared Oct 29, 2025
Meduloc Intramedullary Fracture Fixation (IFF) System
K250316 · JDW
Meduloc, LLC
Orthopedic · 267d
Cleared Oct 28, 2025
Fine Osteotomy™
K253300 · HRS
Bodycad Laboratories, Inc.
Orthopedic · 29d
Cleared Oct 28, 2025
Navigated Instruments
K252742 · OLO
Tyber Medical, LLC
Orthopedic · 61d
Cleared Oct 28, 2025
UniSpace® TPLIF Cage
K252351 · MAX
Cg Medtech Co., Ltd.
Orthopedic · 91d
Cleared Oct 27, 2025
OsteoCentric Navigated Instruments System
K250520 · OLO
Osteocentric Technologies, Inc.
Orthopedic · 248d
Cleared Oct 24, 2025
Expandable Titanium PLIF/TLIF System
K253377 · MAX
Spectrum Spine, Inc.
Orthopedic · 24d