HXKClass I

Holder, Needle; Orthopedic

21 CFR 888.4540 / Orthopedic

HXK is the FDA product code for Holder, Needle; Orthopedic, 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 1989-02-03, and 5 recalls.

Classification record

Product code: HXK
Device name: Holder, Needle; Orthopedic
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: 5

Clearances, product code HXK

By decision year

5 clearances under product code HXK with a decision year between 1978 and 1989, 1978 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code HXK by decision year
Year	Clearances
1978	1
1980	1
1986	1
1987	1
1989	1

Applicants with the most clearances

Product code HXK

Applicants holding the most 510(k) clearances under product code HXK
Applicant	Clearances
Ace Orthopedic Manufacturing Co.	1
Buckman Co., Inc.	1
Dhason Brothers, Inc.	1
Edward Weck, Inc.	1
Micrins Surgical, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 232 companies shown, in name order