HXYClass I

Brace, Drill

21 CFR 888.4540 / Orthopedic

HXY is the FDA product code for Brace, Drill, a class I device type, regulated under 21 CFR 888.4540. As of 2026-09-10, FDA records hold 7 510(k) clearances under this code, the most recent dated 1992-11-06, and one recall.

Classification record

Product code: HXY
Device name: Brace, Drill
Regulation: 21 CFR 888.4540
Device class: Class I
Review panel: Orthopedic
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 7
Ingested recalls: 1

Clearances, product code HXY

By decision year

7 clearances under product code HXY with a decision year between 1977 and 1992, 1988 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code HXY by decision year
Year	Clearances
1977	1
1983	1
1988	3
1989	1
1992	1

Applicants with the most clearances

Product code HXY

Applicants holding the most 510(k) clearances under product code HXY
Applicant	Clearances
Mizuho Orthopedic Systems Inc	2
Austin Assoc.	1
Buckman Co., Inc.	1
Depuy, Inc.	1
Mitek Surgical Products, Inc.	1
Neimark Labs, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 88 companies shown, in name order