KWQClass II

Appliance, Fixation, Spinal Intervertebral Body

21 CFR 888.3060 / Orthopedic

KWQ is the FDA product code for Appliance, Fixation, Spinal Intervertebral Body, a class II device type, regulated under 21 CFR 888.3060. As of 2026-09-10, FDA records hold 667 510(k) clearances under this code, the most recent dated 2026-07-16, and 214 recalls.

Classification record

Product code: KWQ
Device name: Appliance, Fixation, Spinal Intervertebral Body
Regulation: 21 CFR 888.3060
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: 668
Ingested recalls: 214

Clearances, product code KWQ

By decision year

668 clearances under product code KWQ with a decision year between 1979 and 2026, 2004 the highest year at 37.

Show the numbers

510(k) clearances under FDA product code KWQ by decision year
Year	Clearances
1979	4
1980	1
1982	1
1983	1
1984	1
1985	2
1988	1
1991	2
1992	7
1993	7
1994	6
1995	9
1996	4
1997	16
1998	13
1999	18
2000	24
2001	11
2002	25
2003	20
2004	37
2005	25
2006	22
2007	27
2008	32
2009	23
2010	23
2011	22
2012	26
2013	22
2014	17
2015	25
2016	15
2017	20
2018	22
2019	26
2020	26
2021	17
2022	18
2023	16
2024	17
2025	7
2026	10

Applicants with the most clearances

Product code KWQ

Applicants holding the most 510(k) clearances under product code KWQ
Applicant	Clearances
NuVasive Inc	21
K2M, Inc	20
Medtronic Sofamor Danek	20
Howmedica Osteonics Corp	16
Globus Medical, Inc.	15
Life Spine	14
Aesculap Inc	13
Blackstone Medical, Inc.	13
Synthes (USA) Products LLC	13
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	12

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 327 companies shown, in name order