HTXClass I

Rongeur

21 CFR 888.4540 / Orthopedic

HTX is the FDA product code for Rongeur, a class I device type, regulated under 21 CFR 888.4540. As of 2026-09-10, FDA records hold 5 510(k) clearances under this code, the most recent dated 1987-12-30, and 7 recalls.

Classification record

Product code: HTX
Device name: Rongeur
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: 5
Ingested recalls: 7

Clearances, product code HTX

By decision year

5 clearances under product code HTX with a decision year between 1976 and 1987, 1984 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code HTX by decision year
Year	Clearances
1976	1
1978	1
1984	2
1987	1

Applicants with the most clearances

Product code HTX

Applicants holding the most 510(k) clearances under product code HTX
Applicant	Clearances
Plastafil, Inc.	2
Depuy, Inc.	1
Orthopedic Equipment Co., Inc.	1
Solway, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 317 companies shown, in name order