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
433–456 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 15, 2025
OptiMesh Multiplanar Expandable Interbody Fusion System
K251302 · OQB
Spineology, Inc.
Orthopedic · 231d
Cleared Dec 12, 2025
Affixus® Natural Nail® Proximal Humeral System
K253749 · HSB
Zimmer Switzerland Manufacturing GmbH
Orthopedic · 17d
Cleared Dec 11, 2025
Cervical Spine Truss System - Stand Alone (CSTS-SA)
K253200 · OVE
4Web Medical, Inc.
Orthopedic · 76d
Cleared Dec 11, 2025
HyperFlex® Bunion Correction System
K252997 · HRS
Hyperflex Medical
Orthopedic · 84d
Cleared Dec 11, 2025
APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw)
K252897 · HRS
A Plus Biotechnology Co., Ltd.
Orthopedic · 91d
Cleared Dec 11, 2025
KLS Martin Pure Pectus System
K250988 · HRS
KLS-Martin L.P.
Orthopedic · 255d
Cleared Dec 10, 2025
ARIX Femur Nail System
K252826 · HSB
Jeil Medical Corporation
Orthopedic · 96d
Cleared Dec 08, 2025
DeGen Medical Patient Specific Implant (PSI) System
K251829 · OVD
Degen Medical
Orthopedic · 178d
Cleared Dec 05, 2025
REAL INTELLIGENCE™ CORI™ XT (CORI XT)
K252841 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 88d
Cleared Dec 05, 2025
Velora Acetabular System
K252067 · LPH
Restor3D, Inc.
Orthopedic · 157d
Cleared Dec 05, 2025
PUREVUE™ FMS
K250795 · HRX
W.O.M. World of Medicine GmbH
Orthopedic · 266d
Cleared Dec 05, 2025
SpineLinc Anterior Cervical Implant System
K250764 · ODP
Lincotek Medical
Orthopedic · 267d
Cleared Dec 05, 2025
VSP Orthopedics System
K250711 · PBF
3D Systems, Inc.
Orthopedic · 270d
Cleared Dec 04, 2025
Tigon Medical Knotless and Dual Javelin All-Suture Anchors
K252596 · MBI
Tigon Medical
Orthopedic · 111d
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