Medical Device Manufacturer · US , Dedham , MA

Mitek Surgical Products, Inc. - FDA 510(k) Cleared Devices

31 submissions · 26 cleared · Since 1989

31

Total

26

Cleared

0

Denied

FDA 510(k) Regulatory Record - Mitek Surgical Products, Inc. Orthopedic ✕

21 devices

1-21 of 21

Cleared Jan 31, 1996

MITEK THREADED ANCHOR (FASTIN)

Orthopedic · 195d

Cleared Dec 29, 1995

MITEK GII ANCHOR

Orthopedic · 165d

Cleared May 22, 1995

MITEK TOGGLE ANCHOR(TM)

Orthopedic · 133d

Cleared Mar 24, 1995

MITEK G III ANCHOR, MITEK LS ANCHOR

Orthopedic · 169d

Cleared Mar 06, 1995

MITEK THRADED ANCHOR (MTA)

Orthopedic · 132d

Cleared Oct 07, 1994

MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER

Orthopedic · 395d

Cleared Jul 22, 1994

MITEK GIII ANCHOR

Orthopedic · 469d

Cleared Jun 16, 1994

Orthopedic · 461d

Cleared Jan 07, 1994

MITEK MINI ANCHOR, MODIFICATION

Orthopedic · 339d

Cleared Dec 08, 1993

MITEK SUPER QUICKANCHOR, MODIFICATION

Orthopedic · 313d

Cleared Oct 22, 1993

MITEK LIGAMENT ANCHOR

Orthopedic · 308d

Cleared Oct 27, 1992

Orthopedic · 47d

Cleared Oct 22, 1992

MITEK BONE ANCHOR, MODIFICATION

Orthopedic · 307d

Cleared Jun 09, 1992

QUICKANCHOR, MODIFICATION

Orthopedic · 62d

Cleared May 01, 1992

MITEK ANCHOR, MITEK ANCHOR II

Orthopedic · 106d

Cleared Jan 04, 1991

Orthopedic · 52d

Cleared Jul 24, 1990

MITEK ANCHOR II

Orthopedic · 32d

Cleared Apr 04, 1990

MITEK ANCHOR(TM)

Orthopedic · 99d

Cleared Oct 06, 1989

MITEK ANCHOR DRILL

Orthopedic · 169d

Cleared Sep 28, 1989

MITEK DRILL GUIDE

Orthopedic · 161d

Cleared Sep 19, 1989

Orthopedic · 173d