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510(k) K892904

MITEK DRILL GUIDE by Mitek Surgical Products, Inc. — Product Code HXY

K892904 is an FDA 510(k) premarket notification submitted by Mitek Surgical Products, Inc. for the device "MITEK DRILL GUIDE". The FDA issued a decision of Substantially Equivalent on September 28, 1989. The device falls under product code HXY (Brace, Drill), a Class I device regulated under 21 CFR 888.4540. Mitek Surgical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1989
Date Received
April 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Brace, Drill
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
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 HXY

  • K923776 — BENDEREV DRILL GUIDE (November 6, 1992)
  • K880264 — BONE SUTURE FIXATION DEVICE (March 23, 1988)
  • K880381 — TELOS DISTAL TARGETING DEVICE (March 15, 1988)
  • K880046 — HASTING FINGER FIXATOR INSTRUMENTS (February 16, 1988)
  • K831043 — ANDREWS REMOTE CHUCK DRILL (April 28, 1983)
  • K770204 — CEMENT EXTRACTOR DRILL (February 8, 1977)

FDA data resources