510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K892904Substantially Equivalent

Mitek Drill Guide

Mitek Surgical Products, Inc., Dedham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892904 is the FDA 510(k) clearance record for MITEK DRILL GUIDE, a class I device, cleared for Mitek Surgical Products, Inc. on under FDA product code HXY (Brace, Drill). FDA records list 31 510(k) clearances for Mitek Surgical Products, Inc., from to . As of , FDA records show no recalls naming K892904.

Clearance record

Decision date
Received
(161 days to decision)
Product code
HXY Brace, Drill
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Mitek Surgical Products, Inc. 990 Washington St., Dedham MA
Third party review
No

Clearances, product code HXY

Trailing 12 months

FDA records hold no clearances under product code HXY in the trailing twelve months.

FDA records show no clearances under product code HXY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HXY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260