LXHClass I

Orthopedic Manual Surgical Instrument

21 CFR 888.4540 / Orthopedic

LXH is the FDA product code for Orthopedic Manual Surgical Instrument, a class I device type, regulated under 21 CFR 888.4540. As of 2026-09-10, FDA records hold 58 510(k) clearances under this code, the most recent dated 2019-12-20, and 526 recalls.

Classification record

Product code: LXH
Device name: Orthopedic Manual Surgical Instrument
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: 58
Ingested recalls: 526

Clearances, product code LXH

By decision year

58 clearances under product code LXH with a decision year between 1980 and 2019, 1989 the highest year at 12.

Show the numbers

510(k) clearances under FDA product code LXH by decision year
Year	Clearances
1980	2
1981	2
1982	1
1984	6
1985	2
1986	1
1988	4
1989	12
1990	8
1992	5
1993	1
1994	7
1995	2
1996	1
2000	1
2010	1
2014	1
2019	1

Applicants with the most clearances

Product code LXH

Applicants holding the most 510(k) clearances under product code LXH
Applicant	Clearances
Dhason Brothers, Inc.	10
Advanced Med/Surg, Inc.	4
Mumtaz I. Malik	4
Onyx Medical LLC	3
Acufex Microsurgical, Inc.	2
Karlin Technology, Inc.	2
Mizuho Orthopedic Systems Inc	2
Stainless Mfg., Inc.	2
Stryker Corp.	2
Biomedical Devices, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 1,029 companies shown, in name order