FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,766 results
4681–4704 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 28, 2017
Biomet Knee Joint Replacement Prostheses
K171054 · JWH
Biomet, Inc.
Orthopedic · 109d
Cleared Jul 27, 2017
ARIX Ankle Distal Tibia System
K170313 · HRS
Jeil Medical Corporation
Orthopedic · 176d
Cleared Jul 25, 2017
LumFuse-TP
K171630 · MAX
Precifit Medical, Ltd.
Orthopedic · 53d
Cleared Jul 25, 2017
ANCHORMAN Tibial Ligament Fixation Device
K170388 · MBI
Summit Medical , Ltd.
Orthopedic · 167d
Cleared Jul 24, 2017
Klassic HD® Hip System
K171962 · LPH
Total Joint Othopedics, Inc.
Orthopedic · 24d
Cleared Jul 24, 2017
Rampart L Lumbar Interbody Fusion Device
K171724 · MAX
Spineology, Inc.
Orthopedic · 42d
Cleared Jul 24, 2017
True Spinal Fixation System
K171559 · NKB
Innovative Surgical Designs, Inc.
Orthopedic · 55d
Cleared Jul 24, 2017
ARIX Diaphysis System
K171285 · HRS
Jeil Medical Corporation
Orthopedic · 84d
Cleared Jul 24, 2017
JAWS(TM) Nitinol Staple System
K170923 · JDR
Paragon 28
Orthopedic · 117d
Cleared Jul 24, 2017
DRACO Locking Bone Screws
K163486 · KTT
Hnm Total Recon, LLC
Orthopedic · 224d
Cleared Jul 20, 2017
EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical...
K171439 · KWQ
Medos International SARL
Orthopedic · 65d
Cleared Jul 20, 2017
CONCORDE LIFT
K171425 · MAX
Medos International SARL
Orthopedic · 66d
Cleared Jul 20, 2017
dynaMX Intramedullary Implant
K170326 · HTY
Arthrex, Inc.
Orthopedic · 168d
Cleared Jul 20, 2017
SIGN IM Nail
K163589 · HSB
Sign Fracture Care International
Orthopedic · 212d
Cleared Jul 19, 2017
TiLock2 Spinal System
K171838 · NKB
Genesys Spine
Orthopedic · 29d
Cleared Jul 17, 2017
Genius Total Knee System
K170613 · JWH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 138d
Cleared Jul 17, 2017
U2 Femoral Head
K162957 · LPH
United Orthopedic Corporation
Orthopedic · 266d
Cleared Jul 14, 2017
Vitality® Spinal Fixation System
K171907 · NKB
Zimmer Biomet Spine, Inc.
Orthopedic · 18d
Cleared Jul 14, 2017
HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System
K171413 · NQW
Globus Medical, Inc.
Orthopedic · 60d
Cleared Jul 14, 2017
True Spinal Fixation System
K170710 · NKB
Innovative Surgical Designs, Inc.
Orthopedic · 128d
Cleared Jul 14, 2017
In2Bones Fracture and Correction System
K170518 · HRS
In2bones USA, LLC
Orthopedic · 143d
Cleared Jul 14, 2017
Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System
K162153 · HWC
Ascension Orthopedics
Orthopedic · 346d
Cleared Jul 13, 2017
OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System
K171813 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 24d
Cleared Jul 13, 2017
Velofix(tm) Interbody Fusion System
K171749 · ODP
U&I Corporation
Orthopedic · 30d