510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K853762Substantially Equivalent

Isometric Acl Drill Guide

Mizuho Orthopedic Systems Inc, Hayward CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853762 is the FDA 510(k) clearance record for ISOMETRIC ACL DRILL GUIDE, a class I device, cleared for Orthopedic Systems, Inc. on under FDA product code GEY (Motor, Surgical Instrument, Ac-Powered). FDA records list 95 510(k) clearances for MIZUHO ORTHOPEDIC SYSTEMS, INC., from to . As of , FDA records show no recalls naming K853762.

Clearance record

Decision date
Received
(28 days to decision)
Product code
GEY Motor, Surgical Instrument, Ac-Powered
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Orthopedic Systems, Inc. 1897 National Ave., Hayward CA
Third party review
No

Clearances, product code GEY

Trailing 12 months

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

FDA records show no clearances under product code GEY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GEY, 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