Medical Device Manufacturer · US , Naples , FL

Arthrex, Inc. - FDA 510(k) Cleared Devices

357 submissions · 353 cleared · Since 1992
357
Total
353
Cleared
0
Denied
318 devices
151-175 of 318
Cleared Dec 15, 2016
Arthrex iBalance UKA System Vitamin E Tibial Bearing
K161060 · HSX
Orthopedic · 244d
Cleared Nov 21, 2016
Arthrex Univers Revers Shoulder Prosthesis System
K161782 · HSD
Orthopedic · 145d
Cleared Aug 29, 2016
Arthrex VaultLock Glenoid
K161108 · KWS
Orthopedic · 131d
Cleared May 10, 2016
FiberTak DR
K160319 · MBI
Orthopedic · 95d
Cleared Apr 19, 2016
Arthrex Univers Revers CA Heads and Adapters
K151527 · HSD
Orthopedic · 316d
Cleared Apr 12, 2016
Arthrex iBalance BiCompartmental Arthroplasty System
K160461 · KRR
Orthopedic · 53d
Cleared Mar 24, 2016
Arthrex SwiveLock Anchors
K151342 · MAI
Orthopedic · 310d
Cleared Feb 23, 2016
Arthrex Short Suture Anchors
K151092 · MBI
Orthopedic · 306d
Cleared Feb 19, 2016
Arthrex iBalance TKA System
K153586 · MBH
Orthopedic · 65d
Cleared Nov 23, 2015
Arthrex Univers Apex, Size 5 Stem
K153115 · KWS
Orthopedic · 26d
Cleared Nov 16, 2015
Arthrex iBalance TKA System
K152252 · MBH
Orthopedic · 98d
Cleared Nov 12, 2015
Arthrex iBalance TKA System
K152382 · JWH
Orthopedic · 80d
Cleared Aug 28, 2015
Arthrex Fracture Plates
K151732 · HRS
Orthopedic · 63d
Cleared Aug 20, 2015
Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock...
K150648 · MBI
Orthopedic · 161d
Cleared Jul 02, 2015
Arthrex Corkscrew and SwiveLock Suture Anchors
K143745 · MBI
Orthopedic · 183d
Cleared Jun 19, 2015
Arthrex FiberTak Anchors
K151230 · MBI
Orthopedic · 42d
Cleared May 15, 2015
Arthrex RetroFusion Screw
K151078 · HWC
Orthopedic · 23d
Cleared Apr 29, 2015
Arthrex Plates, Screws, and Staples
K150456 · HRS
Orthopedic · 68d
Cleared Apr 09, 2015
Arthrex Blunt Tip Screws with Fiber Tape
K143702 · HTY
Orthopedic · 106d
Cleared Apr 03, 2015
Arthrex Distal Radius System
K143749 · HRS
Orthopedic · 93d
Cleared Jan 16, 2015
Arthrex Fracture System
K143139 · HRS
Orthopedic · 74d
Cleared Jan 16, 2015
Arthrex Low Profile Screws
K143614 · HWC
Orthopedic · 28d
Cleared Dec 18, 2014
ARTHREX SUTURETAK SUTURE ANCHORS
K140855 · MAI
Orthopedic · 259d
Cleared Nov 25, 2014
Univers Rivers Shoulder Prosthesis System
K142863 · PHX
Orthopedic · 55d
Cleared Nov 19, 2014
Arthrex iBalance Patella Implant, Dome
K143047 · JWH
Orthopedic · 27d

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