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
1777–1800 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 19, 2023
Klassic Knee Revision System
K230537 · JWH
Total Joint Othopedics, Inc.
Orthopedic · 81d
Cleared May 19, 2023
Triathlon® Hinge Knee System
K230416 · KRO
Stryker
Orthopedic · 92d
Cleared May 19, 2023
Ventana™ C Spinal System
K222833 · ODP
Spinal Elements, Inc.
Orthopedic · 241d
Cleared May 19, 2023
Exactech® Alteon® Short Tapered Wedge
K221323 · LZO
Exactech, Inc.
Orthopedic · 378d
Cleared May 18, 2023
Arthrex FiberTak Suture Anchor
K231113 · MBI
Arthrex, Inc.
Orthopedic · 29d
Cleared May 17, 2023
JuggerKnot Soft Anchor
K231128 · MBI
Riverpoint Medical, LLC
Orthopedic · 27d
Cleared May 16, 2023
Eminent Spine 3D Lumbar Interbody Fusion Systems
K230219 · MAX
Eminent Spine, LLC
Orthopedic · 110d
Cleared May 12, 2023
ClariVy™ Cervical IBF System
K230414 · ODP
Vy Spine, LLC
Orthopedic · 85d
Cleared May 12, 2023
EUROSCREW NG
K230394 · MAI
Teknimed
Orthopedic · 87d
Cleared May 11, 2023
JAWS Nitinol Staple System
K230550 · JDR
Paragon 28, Inc.
Orthopedic · 72d
Cleared May 11, 2023
Regeneten Bioinductive Implant
K222501 · OWY
Smith and Nephew, Inc.
Orthopedic · 266d
Cleared May 10, 2023
Internal Joint Stabilizer - Elbow
K223318 · OZI
Skeletal Dynamics, Inc.
Orthopedic · 194d
Cleared May 09, 2023
ATEC Lateral Plate System
K230721 · KWQ
Alphatec Spine, Inc.
Orthopedic · 55d
Cleared May 09, 2023
Catalyst R1 Reverse Shoulder System
K223655 · PHX
Catalyst Orthoscience, Inc.
Orthopedic · 154d
Cleared May 09, 2023
SIRION Lateral Lumbar Interbody System
K223335 · MAX
Astura Medical
Orthopedic · 189d
Cleared May 09, 2023
Latitud™ Hip Replacement System
K222436 · LPH
Meril Healthcare Pvt. , Ltd.
Orthopedic · 270d
Cleared May 05, 2023
Rod Registration Frame
K230989 · OLO
Nu Vasive, Incorporated
Orthopedic · 29d
Cleared May 04, 2023
Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System,...
K230653 · JWH
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared May 04, 2023
ProLift Micro Expandable Spacer System
K223430 · MAX
Life Spine, Inc.
Orthopedic · 171d
Cleared May 04, 2023
OLYMPIC Deformity Band System
K222097 · OWI
Astura Medical
Orthopedic · 290d
Cleared May 03, 2023
ARIX Humerus System
K230938 · HRS
Jeil Medical Corporation
Orthopedic · 30d
Cleared May 03, 2023
PEEK RCI Screw
K230655 · MBI
Signature Orthopaedics Pty, Ltd.
Orthopedic · 55d
Cleared May 03, 2023
Apollo Knotless Suture Anchor
K230123 · MBI
Maruho Medical
Orthopedic · 106d
Cleared May 02, 2023
CoreLink Navigation Instruments
K230880 · OLO
Corelink, LLC
Orthopedic · 33d