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
1753–1776 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 07, 2023
Xenco Medical InterAlign Cervical Interbody System
K223059 · OVE
Xenco Medical, LLC
Orthopedic · 250d
Cleared Jun 06, 2023
F3D Interbody System
K230329 · ODP
Corelink, LLC
Orthopedic · 120d
Cleared Jun 05, 2023
FX V135(TM) Shoulder Prosthesis
K223801 · PHX
Fx Shoulder USA, Inc.
Orthopedic · 168d
Cleared Jun 02, 2023
Fine Osteotomy™
K231314 · PBF
Bodycad Laboratories, Inc.
Orthopedic · 28d
Cleared Jun 02, 2023
APTUS® 3.5 TriLock Straight Plates
K230971 · HRS
Medartis AG
Orthopedic · 58d
Cleared Jun 02, 2023
Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS)...
K230952 · JWH
Howmedica Osteonics Corp., Dba...
Orthopedic · 59d
Cleared Jun 02, 2023
Anatomic PEEK™ Cervical Fusion System with Nanotechnology
K230936 · ODP
Nanovis, LLC
Orthopedic · 60d
Cleared Jun 01, 2023
FiberTak® Suture Anchor
K231330 · MBI
Arthrex, Inc.
Orthopedic · 24d
Cleared May 31, 2023
Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)
K231326 · MAI
Osteonic Co., Ltd.
Orthopedic · 23d
Cleared May 30, 2023
Smith & Nephew ACCORD™ Cable System
K223762 · HRS
Smith & Nephew
Orthopedic · 166d
Cleared May 30, 2023
MyPAO Guides
K220706 · PBF
Medacta International S.A.
Orthopedic · 446d
Cleared May 26, 2023
Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS
K231233 · JWH
Conformis, Inc.
Orthopedic · 28d
Cleared May 26, 2023
CD Horizon™ Spinal System
K231184 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared May 26, 2023
Kodiak Lumbar Spacer System
K230851 · MAX
Met One Technologies, LLC
Orthopedic · 59d
Cleared May 26, 2023
FlexBand
K230316 · OWW
International Life Sciences
Orthopedic · 109d
Cleared May 26, 2023
Dark Star Deformity Pedicle Screw System
K223096 · NKB
Republic Spine, LLC
Orthopedic · 238d
Cleared May 25, 2023
S-COMP Reform® POCT Navigation Instruments
K231229 · OLO
Precision Spine, Inc.
Orthopedic · 27d
Cleared May 25, 2023
KLS Martin LINOS Wrist System
K222624 · HRS
KLS-Martin L.P.
Orthopedic · 267d
Cleared May 25, 2023
Advanced LumFix Spinal Fixation System
K222229 · NKB
CG Bio Co., Ltd.
Orthopedic · 304d
Cleared May 23, 2023
ACTERA™ hip system
K231178 · MEH
Conformis, Inc.
Orthopedic · 27d
Cleared May 23, 2023
Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath
K230874 · MBI
Suzhou Endophix Co., Ltd.
Orthopedic · 54d
Cleared May 22, 2023
Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system)
K230708 · ODP
Gbs Commonwealth Co., Ltd.
Orthopedic · 69d
Cleared May 22, 2023
Integrity™ Bone Staple Fixation System
K223860 · MBI
Anika Therapeutics, Inc.
Orthopedic · 150d
Cleared May 19, 2023
aprevo® transforaminal lumbar interbody fusion device
K231140 · MAX
Carlsmed, Inc.
Orthopedic · 28d