HTZClass I

Instrument, Cutting, Orthopedic

21 CFR 878.4800 / General, Plastic Surgery

HTZ is the FDA product code for Instrument, Cutting, Orthopedic, a class I device type, regulated under 21 CFR 878.4800. As of 2026-09-10, FDA records hold 21 510(k) clearances under this code, the most recent dated 1994-04-15, and 27 recalls.

Classification record

Product code: HTZ
Device name: Instrument, Cutting, Orthopedic
Regulation: 21 CFR 878.4800
Device class: Class I
Review panel: General, Plastic Surgery
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 21
Ingested recalls: 27

Clearances, product code HTZ

By decision year

21 clearances under product code HTZ with a decision year between 1977 and 1994, 1984 the highest year at 11.

Show the numbers

510(k) clearances under FDA product code HTZ by decision year
Year	Clearances
1977	3
1983	1
1984	11
1985	3
1987	1
1994	2

Applicants with the most clearances

Product code HTZ

Applicants holding the most 510(k) clearances under product code HTZ
Applicant	Clearances
Stainless Mfg., Inc.	9
Dentronix, Inc.	2
Synvasive Technology, Inc.	2
American Sterilizer Co.	1
Bowen & Company, Inc.	1
Cerenovus, Inc.	1
Concept, Inc.	1
J. Sklar Mfg. Co., Inc.	1
Ortho Pared Instruments, Inc.	1
Pilling Co.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 215 companies shown, in name order