MNHClass II

Orthosis, Spondylolisthesis Spinal Fixation

21 CFR 888.3070 / Orthopedic

MNH is the FDA product code for Orthosis, Spondylolisthesis Spinal Fixation, a class II device type, regulated under 21 CFR 888.3070. As of 2026-09-10, FDA records hold 309 510(k) clearances under this code, the most recent dated 2016-12-02, and 15 recalls.

Classification record

Product code: MNH
Device name: Orthosis, Spondylolisthesis Spinal Fixation
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: 309
Ingested recalls: 15

Clearances, product code MNH

By decision year

309 clearances under product code MNH with a decision year between 1995 and 2016, 1995 the highest year at 32.

Show the numbers

510(k) clearances under FDA product code MNH by decision year
Year	Clearances
1995	32
1996	14
1997	13
1998	16
1999	11
2000	23
2001	20
2002	22
2003	11
2004	11
2005	13
2006	18
2007	5
2008	13
2009	13
2010	10
2011	17
2012	7
2013	10
2014	12
2015	10
2016	8

Applicants with the most clearances

Product code MNH

Applicants holding the most 510(k) clearances under product code MNH
Applicant	Clearances
Medtronic Sofamor Danek	17
Acromed Corp.	14
Depuyacromed	13
Howmedica Osteonics Corp	13
Sofamor Danek USA,Inc.	9
Advanced Spine Fixation Systems, Inc.	8
Ebi, LLC	6
Ortho Tec, LLC	6
Solco Biomedical Corp.	6
Synthes (USA) Products LLC	6

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 293 companies shown, in name order