HXCClass I

Wrench

21 CFR 888.4540 / Orthopedic

HXC is the FDA product code for Wrench, a class I device type, regulated under 21 CFR 888.4540. As of 2026-09-10, FDA records hold 6 510(k) clearances under this code, the most recent dated 2018-03-08, and 8 recalls.

Classification record

Product code: HXC
Device name: Wrench
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: 6
Ingested recalls: 8

Clearances, product code HXC

By decision year

6 clearances under product code HXC with a decision year between 1979 and 2018, 1987 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code HXC by decision year
Year	Clearances
1979	1
1981	1
1987	3
2018	1

Applicants with the most clearances

Product code HXC

Applicants holding the most 510(k) clearances under product code HXC
Applicant	Clearances
Med-Tool, Inc.	2
Gauthier Biomedical, Inc.	1
Jerome Medical	1
Truth, Inc.	1
Twin City Surgical, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 243 companies shown, in name order