Medical Device Manufacturer · US , Westwood , MA

Mitek Products - FDA 510(k) Cleared Devices

30 submissions · 30 cleared · Since 1996
30
Total
30
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mitek Products Orthopedic
22 devices
1-22 of 22
Cleared Mar 14, 2002
MITEK BIOCRYL INTERFERENCE SCREWS
K013572 · HWC
Orthopedic · 136d
Cleared Feb 06, 2002
RIDIDFIX 2.7MM BTB CROSS PIN KIT
K013781 · HTY
Orthopedic · 84d
Cleared May 09, 2001
RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM
K010633 · HWC
Orthopedic · 68d
Cleared Feb 15, 2001
MITEK 2GII MENISCAL REPAIR SYSTEM
K002406 · MAI
Orthopedic · 192d
Cleared Oct 27, 2000
MITEK CUFFTACK
K003076 · MAI
Orthopedic · 24d
Cleared Aug 31, 2000
VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM
K002402 · HRX
Orthopedic · 24d
Cleared Dec 02, 1999
TALON ANCHOR SNAP-PAK
K993261 · MBI
Orthopedic · 64d
Cleared Sep 24, 1999
VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM
K992876 · HRX
Orthopedic · 29d
Cleared Sep 22, 1999
MITEK ROTATOR CUFF QUICKANCHOR PLUS
K992611 · HWC
Orthopedic · 49d
Cleared Sep 21, 1999
MITEK MINI QUICKANCHOR PLUS
K992487 · HWC
Orthopedic · 57d
Cleared Nov 23, 1998
MITEK FASTIN RC ANCHOR
K983818 · MBI
Orthopedic · 25d
Cleared Aug 24, 1998
MITEK MICRO ANCHOR
K982420 · JDR
Orthopedic · 70d
Cleared Apr 16, 1998
MITEK BTB ABSORBABLE (PLA) CROSS PIN
K974341 · HTY
Orthopedic · 149d
Cleared Mar 05, 1998
MITEK BTB ABSORBABLE (PLA) CROSS PIN
K974291 · HTY
Orthopedic · 111d
Cleared Feb 13, 1998
MITEK KNOTLESS ANCHOR
K974345 · MBI
Orthopedic · 86d
Cleared Jan 30, 1998
MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX
K970119 · MBI
Orthopedic · 381d
Cleared Nov 10, 1997
MITEK NON ABSORBABLE POLYPROPYLENE H FIX
K973009 · MBI
Orthopedic · 89d
Cleared Mar 10, 1997
MITEK SUTURE RETROGRADER
K970360 · HWQ
Orthopedic · 38d
Cleared Feb 24, 1997
MITEK ABSORBABLE TOGGLE ANCHOR
K964013 · MAI
Orthopedic · 140d
Cleared Nov 06, 1996
MITEK MICRO ANCHOR
K962511 · MBI
Orthopedic · 132d
Cleared Oct 03, 1996
MITEK THREADED ANCHOR (MODIFICATION)
K961094 · MBI
Orthopedic · 203d
Cleared Oct 01, 1996
MITEK MICRO ANCHOR
K962793 · JDR
Orthopedic · 76d
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