Medical Device Manufacturer · US , Naples , FL

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

346 submissions · 342 cleared · Since 1992
346
Total
342
Cleared
0
Denied
307 devices
201-225 of 307
Cleared Mar 18, 2010
ARTHREX TIBIAL GRAFTBOLT
K093912 · MBI
Orthopedic · 86d
Cleared Aug 28, 2009
ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS
K091844 · MAI
Orthopedic · 67d
Cleared Aug 06, 2009
MINI TIGHTROPE
K090107 · HTN
Orthopedic · 203d
Cleared Aug 03, 2009
ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE
K083707 · HRX
Orthopedic · 231d
Cleared Jun 26, 2009
ARTHREX UNIVERS II SHOULDER PEGGED GLENOID
K083435 · KWS
Orthopedic · 218d
Cleared Jan 23, 2009
ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK,...
K082810 · MAI
Orthopedic · 121d
Cleared Dec 30, 2008
ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART
K082999 · MAI
Orthopedic · 83d
Cleared Feb 13, 2008
ARTHREX COMPRESSION STAPLE
K080111 · JDR
Orthopedic · 28d
Cleared Jan 17, 2008
ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT
K071456 · MAI
Orthopedic · 237d
Cleared Aug 20, 2007
ARTHREX UNIVERS II SHOULDER PROSTHESIS
K071032 · KWS
Orthopedic · 131d
Cleared Aug 15, 2007
MINI TIGHTROPE FT REPAIR KIT
K071978 · HTN
Orthopedic · 28d
Cleared Aug 03, 2007
MODIFICATION TO: ARTHREX INTERFERENCE SCREW
K071176 · MAI
Orthopedic · 98d
Cleared Jun 29, 2007
ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE...
K071177 · HWC
Orthopedic · 63d
Cleared Mar 06, 2007
ARTHREX CROSSPIN, MODEL AR-1964P
K063719 · HTY
Orthopedic · 81d
Cleared Jan 03, 2007
ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS
K063058 · KWD
Orthopedic · 90d
Cleared Dec 13, 2006
ARTHREX PUSHLOCK
K063479 · HWC
Orthopedic · 26d
Cleared Nov 29, 2006
ARTHREX INTERFERENCE SCREW
K062466 · MAI
Orthopedic · 97d
Cleared Oct 31, 2006
MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS
K061925 · HTN
Orthopedic · 116d
Cleared Oct 19, 2006
ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY
K061863 · HWC
Orthopedic · 111d
Cleared Sep 29, 2006
ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM
K062747 · HRS
Orthopedic · 15d
Cleared Sep 27, 2006
ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES
K062679 · HWC
Orthopedic · 19d
Cleared Jul 25, 2006
ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT
K061665 · HWC
Orthopedic · 41d
Cleared May 19, 2006
ARTHREX BIO-COMPRESSION SCREW
K060478 · HWC
Orthopedic · 85d
Cleared Apr 03, 2006
ARTHREX ARTHOERESIS IMPLANT
K053543 · HWC
Orthopedic · 104d
Cleared Jan 26, 2006
ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS
K053338 · HWC
Orthopedic · 56d

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