LXTClass II

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

21 CFR 888.3030 / Orthopedic

LXT is the FDA product code for Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite, a class II device type, regulated under 21 CFR 888.3030. As of 2026-09-10, FDA records hold 57 510(k) clearances under this code, the most recent dated 2023-09-22, and 14 recalls.

Classification record

Product code: LXT
Device name: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Regulation: 21 CFR 888.3030
Device class: Class II
Review panel: Orthopedic
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 57
Ingested recalls: 14

Clearances, product code LXT

By decision year

57 clearances under product code LXT with a decision year between 1986 and 2023, 2000 the highest year at 10.

Show the numbers

510(k) clearances under FDA product code LXT by decision year
Year	Clearances
1986	1
1988	1
1994	1
1995	2
1996	6
1998	1
1999	5
2000	10
2001	3
2002	2
2003	7
2004	3
2005	5
2006	3
2007	1
2008	1
2009	1
2011	1
2013	2
2023	1

Applicants with the most clearances

Product code LXT

Applicants holding the most 510(k) clearances under product code LXT
Applicant	Clearances
Synthes (USA) Products LLC	14
Howmedica Osteonics Corp	9
Hand Innovations, Inc.	6
Immedica, Inc.	5
Zimmer GmbH	3
Encore Orthopedics, Inc.	2
A.M. Surgical, Inc.	1
Ace Medical	1
Acumed LLC	1
Applied Osteo Systems, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 77 companies shown, in name order