MNIClass II

Orthosis, Spinal Pedicle Fixation

21 CFR 888.3070 / Orthopedic

MNI is the FDA product code for Orthosis, Spinal Pedicle Fixation, a class II device type, regulated under 21 CFR 888.3070. As of 2026-09-10, FDA records hold 303 510(k) clearances under this code, the most recent dated 2017-10-12, and 213 recalls.

Classification record

Product code: MNI
Device name: Orthosis, Spinal Pedicle 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: 303
Ingested recalls: 213

Clearances, product code MNI

By decision year

303 clearances under product code MNI with a decision year between 1998 and 2017, 2003 the highest year at 24.

Show the numbers

510(k) clearances under FDA product code MNI by decision year
Year	Clearances
1998	13
1999	19
2000	11
2001	18
2002	16
2003	24
2004	20
2005	14
2006	15
2007	20
2008	23
2009	18
2010	16
2011	17
2012	19
2013	14
2014	6
2015	12
2016	7
2017	1

Applicants with the most clearances

Product code MNI

Applicants holding the most 510(k) clearances under product code MNI
Applicant	Clearances
Medtronic Sofamor Danek	23
K2M, Inc	15
Howmedica Osteonics Corp	12
Spine Wave Inc	11
Spinal Concepts, Inc.	8
Spinal USA	8
Alphatec Spine, Inc.	7
Blackstone Medical, Inc.	7
Life Spine	7
Depuyacromed	6

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 307 companies shown, in name order