NDNClass II

Cement, Bone, Vertebroplasty

21 CFR 888.3027 / Orthopedic

NDN is the FDA product code for Cement, Bone, Vertebroplasty, a class II device type, regulated under 21 CFR 888.3027. As of 2026-09-10, FDA records hold 108 510(k) clearances under this code, the most recent dated 2026-01-28, and 86 recalls.

Classification record

Product code: NDN
Device name: Cement, Bone, Vertebroplasty
Regulation: 21 CFR 888.3027
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: 108
Ingested recalls: 86

Clearances, product code NDN

By decision year

108 clearances under product code NDN with a decision year between 2004 and 2026, 2011 the highest year at 11.

Show the numbers

510(k) clearances under FDA product code NDN by decision year
Year	Clearances
2004	3
2005	6
2006	10
2007	9
2008	1
2009	6
2010	5
2011	11
2012	7
2013	7
2014	7
2015	6
2016	4
2017	5
2018	3
2019	2
2020	4
2021	2
2022	2
2023	2
2024	3
2025	2
2026	1

Applicants with the most clearances

Product code NDN

Applicants holding the most 510(k) clearances under product code NDN
Applicant	Clearances
Stryker Corp.	11
Medtronic, Inc.	9
ArthroCare Corporation	6
Teknimed SAS	6
Tecres SpA	5
Disc-O-Tech Medical Technologies, Ltd.	4
Osseon, LLC	3
Pan Medical, Ltd.	3
Xelite Biomed, Ltd.	3
Aap Biomaterials GmbH	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 101 companies shown, in name order