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510(k) K935225

MITEK MODULAR DRILL BIT by Mitek Surgical Products, Inc. — Product Code GFG

K935225 is an FDA 510(k) premarket notification submitted by Mitek Surgical Products, Inc. for the device "MITEK MODULAR DRILL BIT". The FDA issued a decision of Substantially Equivalent on April 7, 1994. The device falls under product code GFG (Bit, Surgical), a Class I device regulated under 21 CFR 878.4820. Mitek Surgical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1994
Date Received
November 1, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bit, Surgical
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by Mitek Surgical Products, Inc.

  • K953560 — MITEK THREADED ANCHOR (FASTIN) (January 31, 1996)
  • K953877 — MITEK GII ANCHOR (December 29, 1995)
  • K936311 — MITEK MINI ANCHOR (October 31, 1995)
  • K941599 — MITEK ABSORBABLE ANCHOR (October 24, 1995)
  • K944051 — ABSORBALBE ANCHOR (August 2, 1995)
  • K950070 — MITEK TOGGLE ANCHOR(TM) (May 22, 1995)
  • K944936 — MITEK G III ANCHOR, MITEK LS ANCHOR (March 24, 1995)
  • K945203 — MITEK THRADED ANCHOR (MTA) (March 6, 1995)
  • K934366 — MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER (October 7, 1994)
  • K931782 — MITEK GIII ANCHOR (July 22, 1994)

Other clearances for product code GFG

  • K821486 — MICRO DRILLS (June 9, 1982)
  • K821127 — KEY DRILL (June 3, 1982)

FDA data resources