NKBClass II

Thoracolumbosacral Pedicle Screw System

21 CFR 888.3070 / Orthopedic

NKB is the FDA product code for Thoracolumbosacral Pedicle Screw System, a class II device type, regulated under 21 CFR 888.3070. FDA's definition for this code reads: "Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion". As of 2026-09-10, FDA records hold 905 510(k) clearances under this code, the most recent dated 2026-07-24, and 181 recalls.

Classification record

Product code: NKB
Device name: Thoracolumbosacral Pedicle Screw System
FDA definition: Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
Regulation: 21 CFR 888.3070
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: 910
Ingested recalls: 182

Clearances, product code NKB

By decision year

910 clearances under product code NKB with a decision year between 2003 and 2026, 2017 the highest year at 63.

Show the numbers

510(k) clearances under FDA product code NKB by decision year
Year	Clearances
2003	7
2004	13
2005	16
2006	20
2007	38
2008	36
2009	44
2010	37
2011	48
2012	60
2013	35
2014	46
2015	55
2016	50
2017	63
2018	56
2019	39
2020	48
2021	32
2022	34
2023	44
2024	39
2025	24
2026	26

Applicants with the most clearances

Product code NKB

Applicants holding the most 510(k) clearances under product code NKB
Applicant	Clearances
Medtronic Sofamor Danek	50
Medtronic Sofamor Danek USA Inc	48
DePuy Spine, Inc.	30
Globus Medical, Inc.	24
Howmedica Osteonics Corp	23
Life Spine	22
Alphatec Spine, Inc.	20
K2M, Inc	17
L&K Biomed Co.,Ltd.	17
Medos International SARL	16

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 374 companies shown, in name order