KWPClass II

Appliance, Fixation, Spinal Interlaminal

21 CFR 888.3050 / Orthopedic

KWP is the FDA product code for Appliance, Fixation, Spinal Interlaminal, a class II device type, regulated under 21 CFR 888.3050. As of 2026-09-10, FDA records hold 430 510(k) clearances under this code, the most recent dated 2015-07-29, and 68 recalls.

Classification record

Product code: KWP
Device name: Appliance, Fixation, Spinal Interlaminal
Regulation: 21 CFR 888.3050
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: 430
Ingested recalls: 68

Clearances, product code KWP

By decision year

430 clearances under product code KWP with a decision year between 1978 and 2015, 2002 the highest year at 30.

Show the numbers

510(k) clearances under FDA product code KWP by decision year
Year	Clearances
1978	2
1979	3
1980	3
1981	2
1982	1
1984	1
1985	6
1986	1
1987	3
1988	9
1989	13
1990	14
1991	9
1992	13
1993	13
1994	14
1995	7
1996	15
1997	13
1998	21
1999	16
2000	15
2001	19
2002	30
2003	17
2004	20
2005	24
2006	9
2007	14
2008	13
2009	12
2010	14
2011	12
2012	18
2013	12
2014	13
2015	9

Applicants with the most clearances

Product code KWP

Applicants holding the most 510(k) clearances under product code KWP
Applicant	Clearances
Medtronic Sofamor Danek	44
Synthes (USA) Products LLC	19
Danek Medical, Inc.	16
Acromed Corp.	14
Howmedica Osteonics Corp	14
Sofamor Danek USA,Inc.	13
K2M, Inc	12
Depuyacromed	10
Medtronic Sofamor Danek USA Inc	10
Sofamor Danek Mfg., Inc.	10

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 291 companies shown, in name order