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
145–168 of 17,899
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 27, 2026
SABER-C System
K260660 · OVE
Elevation Spine
Orthopedic · 56d
Cleared Apr 27, 2026
Avenir® Müller Stem
K260182 · LZO
Zimmer, Inc.
Orthopedic · 96d
Cleared Apr 24, 2026
AUTOBAHN™ Nailing System
K261043 · HSB
Globus Medical, Inc.
Orthopedic · 24d
Cleared Apr 24, 2026
Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip
K261008 · MQV
Stryker Spine
Orthopedic · 29d
Cleared Apr 24, 2026
ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System
K260549 · ODP
Zsfab, Inc.
Orthopedic · 65d
Cleared Apr 24, 2026
PC Fix System
K260411 · HRS
Chest Wall Innovations, Inc.
Orthopedic · 74d
Cleared Apr 24, 2026
POYA 3.5mm Medial Proximal Tibia System
K260228 · HRS
Bonebridge AG
Orthopedic · 88d
Cleared Apr 24, 2026
I.T.S. PRS Phoenix II
K260054 · HRS
I.T.S. GmbH
Orthopedic · 106d
Cleared Apr 24, 2026
Knee+
K253805 · SBF
Pixee Medical S.A.S.
Orthopedic · 147d
Cleared Apr 24, 2026
EPORE® XO cup system
K252451 · OQI
Implantcast GmbH
Orthopedic · 263d
Cleared Apr 22, 2026
corra™ cervical plating system
K260570 · KWQ
Carlsmed, Inc.
Orthopedic · 62d
Cleared Apr 21, 2026
Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
K260921 · MBI
Tigon Medical
Orthopedic · 33d
Cleared Apr 21, 2026
CD Horizon™ ModuLeX™ Fenestrated Screw Set
K260216 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 88d
Cleared Apr 20, 2026
SAGI Cervical Cage System
K253213 · OVE
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 203d
Cleared Apr 17, 2026
TITAN Nail
K260934 · HWC
Medartis AG
Orthopedic · 28d
Cleared Apr 17, 2026
DYNEX® External Fixation Systems
K260900 · KTT
Vilex, LLC
Orthopedic · 30d
Cleared Apr 16, 2026
Foundation Surgical Navigated Lateral Disc Prep Instruments
K260011 · OLO
Foundation Surgical Group, Inc.
Orthopedic · 104d
Cleared Apr 16, 2026
ARx® SAI Implant System
K254274 · NKB
Life Spine, Inc.
Orthopedic · 107d
Cleared Apr 16, 2026
Freedom DS™ Decompression System
K253523 · HRX
Spinal Simplicity
Orthopedic · 154d
Cleared Apr 16, 2026
ORIO-3D Cage System
K253260 · ODP
SpineCraft
Orthopedic · 199d
Cleared Apr 15, 2026
Refobacin Bone Cement R (110034355)
K254107 · LOD
Biomet France
Orthopedic · 117d
Cleared Apr 15, 2026
Uni-C Cervical Cage System
K252774 · OVE
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 225d
Cleared Apr 15, 2026
Comprehensive Reverse Shoulder - HA Glenosphere Baseplates
K252404 · PHX
Biomet Orthopedics
Orthopedic · 258d
Cleared Apr 14, 2026
Equinoxe® Shoulder System
K260583 · PHX
Exactech, Inc.
Orthopedic · 53d