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
121–144 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Jul 01, 2026
Admiral ACP System
K253420 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 273d
Cleared Jun 26, 2026
SALGINA 2.5mm Distal Radius System
K261351 · HRS
Bonebridge AG
Orthopedic · 63d
Cleared Jun 26, 2026
Arthrex FiberButton
K260018 · MBI
Arthrex, Inc.
Orthopedic · 172d
Cleared Jun 26, 2026
VERTICALE® Navigation Instruments
K253921 · OLO
Silony Medical GmbH
Orthopedic · 200d
Cleared Jun 25, 2026
ATTUNE Total Knee System
K261458 · JWH
Depuy Ireland UC
Orthopedic · 55d
Cleared Jun 25, 2026
Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System
K260809 · HWC
Arthrex, Inc.
Orthopedic · 105d
Cleared Jun 25, 2026
VELYS™ Robotic-Assisted Solution
K260480 · OLO
Depuy Ireland UC
Orthopedic · 132d
Cleared Jun 22, 2026
DeltaNEC Interbody System
K261279 · OVE
Nexus Spine
Orthopedic · 66d
Cleared Jun 20, 2026
Dynamis Robotic Surgical System
K260369 · OLO
LEM Surgical AG
Orthopedic · 135d
Cleared Jun 18, 2026
CORUS™ Navigation System-GN
K261665 · OLO
Providence Medical Technology, Inc.
Orthopedic · 29d