Mitek Surgical Products, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
31
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K953560MITEK THREADED ANCHOR (FASTIN)January 31, 1996
K953877MITEK GII ANCHORDecember 29, 1995
K936311MITEK MINI ANCHOROctober 31, 1995
K941599MITEK ABSORBABLE ANCHOROctober 24, 1995
K944051ABSORBALBE ANCHORAugust 2, 1995
K950070MITEK TOGGLE ANCHOR(TM)May 22, 1995
K944936MITEK G III ANCHOR, MITEK LS ANCHORMarch 24, 1995
K945203MITEK THRADED ANCHOR (MTA)March 6, 1995
K934366MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHEROctober 7, 1994
K931782MITEK GIII ANCHORJuly 22, 1994
K931253QUICKANCHOR IIJune 16, 1994
K935225MITEK MODULAR DRILL BITApril 7, 1994
K930892MITEK MINI ANCHOR, MODIFICATIONJanuary 7, 1994
K930893MITEK SUPER QUICKANCHOR, MODIFICATIONDecember 8, 1993
K930675MITEK CONE WASHERNovember 9, 1993
K926270MITEK LIGAMENT ANCHOROctober 22, 1993
K923161BRAIDED POLYESTER SUTURE MATERIALDecember 30, 1992
K924665QUICKANCHOROctober 27, 1992
K915889MITEK BONE ANCHOR, MODIFICATIONOctober 22, 1992
K921873QUICKANCHOR, MODIFICATIONJune 9, 1992