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
25–48 of 17,899
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 21, 2026
Versalock Proximal Tibial Plating System
K261406 · HRS
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 83d
Cleared Jul 20, 2026
Thunderbolt System
K261632 · MBI
Responsive Arthroscopy, Inc.
Orthopedic · 63d
Cleared Jul 17, 2026
Tritanium® C Anterior Cervical Cage
K262061 · ODP
Stryker Spine
Orthopedic · 29d
Cleared Jul 17, 2026
Catalyft PL Expandable Interbody System
K253011 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 301d
Not Cleared Jul 17, 2026
SportSuite Vision Software
DEN250040 · SIT
Stryker Endoscopy
Orthopedic · 318d
Cleared Jul 16, 2026
TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD)
K262032 · HRS
TriMed, Inc.
Orthopedic · 29d
Cleared Jul 16, 2026
Palisades™ Buttress Plate System
K261309 · KWQ
Bethesda Medical Devices, LLC
Orthopedic · 86d
Cleared Jul 16, 2026
Cable-Ready® Cable Grip System
K261271 · JDQ
Pioneer Surgical Technology, Inc.
Orthopedic · 90d
Cleared Jul 15, 2026
Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System
K261353 · OVD
Kyocera Medical Technologies, Inc.
Orthopedic · 82d
Cleared Jul 15, 2026
Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant
K252822 · PLR
Atlas Spine, Inc.
Orthopedic · 314d
Cleared Jul 14, 2026
Invictus® Small Stature Spinal Fixation System
K261284 · NKB
Alphatec Spine, Inc.
Orthopedic · 88d
Cleared Jul 14, 2026
Symmetrix™ L Spinal System
K261020 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 109d
Cleared Jul 10, 2026
Omnifit® 20° Series I Insert
K261624 · LPH
Howmedica Osteonics Corp., Dba...
Orthopedic · 56d
Cleared Jul 10, 2026
POSEIDON ST
K261031 · MQP
Signus Medinzintechnik GmbH
Orthopedic · 102d
Cleared Jul 09, 2026
Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue...
K261968 · MBI
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Jul 08, 2026
Alians Elbow S
K261191 · HRS
Newclip Technics
Orthopedic · 86d
Cleared Jul 08, 2026
C.A. Medical Interbody Fusion System
K254130 · ODP
C.A. Medical, LLC
Orthopedic · 198d
Cleared Jul 06, 2026
MobileLink Acetabular Cup System – 40mm ID Inserts (various)
K261009 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 102d
Not Cleared Jul 06, 2026
TESSA Spatial Surgery System
DEN250037 · SIQ
Smith & Nephew, Inc.
Orthopedic · 318d
Cleared Jul 01, 2026
OTS Hip
K261852 · OLO
Ortoma AB
Orthopedic · 28d
Cleared Jul 01, 2026
RibPlate System
K261054 · HRS
Stryker Leibinger GmbH & Co KG
Orthopedic · 92d
Cleared Jul 01, 2026
Veritas Shoulder System
K260556 · PHX
Restor3d
Orthopedic · 132d
Cleared Jul 01, 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K253802 · NKB
S.M.A.I.O
Orthopedic · 215d
Cleared Jul 01, 2026
OSSTM Orthopedic Salvage System
K253434 · JDI
Biomet, Inc.
Orthopedic · 273d