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
529–552 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 30, 2025
External Fixation Mini Rail System
K252106 · KTT
Paragon 28, Inc.
Orthopedic · 89d
Cleared Sep 30, 2025
Allomatrix (Allomatrix Injectable Putty
K252085 · MQV
Wright Medical Technology, Inc....
Orthopedic · 90d
Cleared Sep 30, 2025
Arthrex SpeedFLEX™ Implant
K251690 · OWY
Arthrex, Inc.
Orthopedic · 120d
Cleared Sep 29, 2025
UltraGuideCTR® image guided soft tissue release system
K252594 · HRX
Sonex Health
Orthopedic · 45d
Cleared Sep 29, 2025
SpineAR SNAP (SyncAR Spine)
K252054 · SBF
Surgical Theater, Inc.
Orthopedic · 90d
Cleared Sep 26, 2025
Inset Reverse Total Shoulder System
K252221 · PHX
Shoulder Innovations, Inc.
Orthopedic · 72d
Cleared Sep 25, 2025
Stem Extension Line (U2 Total Knee System—PSA Type)
K252725 · JWH
United Orthopedic Corporation
Orthopedic · 28d
Cleared Sep 25, 2025
RPS Primary TKA Software
K251971 · OLO
Stryker Instruments
Orthopedic · 91d
Cleared Sep 25, 2025
Auxano® Wedge Fixation System
K251791 · PLF
Auxano Medical, LLC
Orthopedic · 106d
Cleared Sep 25, 2025
Endeavor™ Stand-Alone Cervical IBF System
K250076 · OVE
Innovasis
Orthopedic · 258d
Cleared Sep 19, 2025
Impact PEEK Union Nail System
K252657 · HTY
Nvision Biomedical Technologies, Inc.
Orthopedic · 28d
Cleared Sep 19, 2025
Tapestry Biointegrative Implant
K252647 · OWY
Embody, Inc.
Orthopedic · 29d
Cleared Sep 19, 2025
Coated hip implants
K250450 · LZO
Medacta International S.A.
Orthopedic · 213d
Cleared Sep 18, 2025
Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody...
K251479 · MAX
Mobarn Medical Devices, LLC
Orthopedic · 128d
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