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
313–336 of 17,899
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 08, 2026
Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)
K252788 · PHX
Tornier, Inc.
Orthopedic · 128d
Cleared Jan 08, 2026
Advantage-C™ Ti3D Cervical Interbody Fusion Device
K252711 · ODP
Intelivation Technologies
Orthopedic · 134d
Cleared Jan 07, 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K253990 · NKB
S.M.A.I.O
Orthopedic · 26d
Cleared Jan 07, 2026
CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)
K253941 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Jan 07, 2026
VyBrate™ VBR System
K253158 · MQP
Vy Spine, LLC
Orthopedic · 103d
Cleared Jan 06, 2026
Materialise TKA Guide System
K253793 · JWH
Materialise NV
Orthopedic · 39d
Cleared Jan 06, 2026
QuadLock™ Fixation System
K253618 · MBI
Abanza Tecnomed S.L
Orthopedic · 49d
Cleared Jan 06, 2026
TRILEAP Plating System
K253178 · HRS
Crossroads Extremity Systems
Orthopedic · 102d
Cleared Jan 06, 2026
aprevo® cervical interbody system
K252894 · ODP
Carlsmed, Inc.
Orthopedic · 117d
Cleared Jan 02, 2026
FiberLocker Implant
K253867 · OWX
ZuriMED Technologies AG
Orthopedic · 30d
Cleared Dec 31, 2025
Tyber Medical Trauma Screw
K252901 · HWC
Tyber Medical, LLC
Orthopedic · 111d
Cleared Dec 30, 2025
Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm
K253895 · MBI
Arthrex, Inc.
Orthopedic · 26d
Cleared Dec 29, 2025
ZipToe™ Hammertoe Fusion System
K253325 · HTY
Toetal Solutions
Orthopedic · 90d
Cleared Dec 23, 2025
OsteoRemedies Hip Spacer System
K253675 · KWL
Osteoremedies, LLC
Orthopedic · 32d
Cleared Dec 23, 2025
Active-V Total Knee System
K253239 · MBH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 85d
Cleared Dec 23, 2025
MiiS Horus Arthroscope (EJA 100)
K253217 · HRX
Medimaging Integrated Solution, Inc...
Orthopedic · 85d
Cleared Dec 22, 2025
HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)
K253876 · OVE
Globus Medical, Inc.
Orthopedic · 18d
Cleared Dec 22, 2025
Syndesmosis TightRope PRO
K253727 · HTN
Arthrex, Inc.
Orthopedic · 28d
Cleared Dec 22, 2025
TMINI Miniature Robotic System
K253661 · OLO
THINK Surgical, Inc.
Orthopedic · 32d
Cleared Dec 22, 2025
aprevo® cervical plating system
K252611 · KWQ
Carlsmed, Inc.
Orthopedic · 126d
Cleared Dec 19, 2025
Monkey Rings External Ring Fixation System
K253613 · KTT
Paragon 28, Inc.
Orthopedic · 31d
Cleared Dec 19, 2025
IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)
K253577 · MAX
Medicrea International S.A.S....
Orthopedic · 32d
Cleared Dec 19, 2025
Hoffmann LRF System
K253202 · KTT
Stryker GmbH
Orthopedic · 84d
Cleared Dec 19, 2025
Balanced Knee System TriMax Porous Femoral Components
K253161 · MBH
Ortho Development Corp.
Orthopedic · 84d