MTZClass II

Wrap, Implant, Orbital

21 CFR 886.3320 / Ophthalmic

MTZ is the FDA product code for Wrap, Implant, Orbital, a class II device type, regulated under 21 CFR 886.3320. As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 2003-02-21, and no recalls.

Classification record

Product code: MTZ
Device name: Wrap, Implant, Orbital
Regulation: 21 CFR 886.3320
Device class: Class II
Review panel: Ophthalmic
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code MTZ

By decision year

2 clearances under product code MTZ with a decision year between 1997 and 2003, 1997 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code MTZ by decision year
Year	Clearances
1997	1
2003	1

Applicants with the most clearances

Product code MTZ

Applicants holding the most 510(k) clearances under product code MTZ
Applicant	Clearances
Bio-Vascular, Inc.	1
Macropore Biosurgery, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code MTZ.

Recent clearances

Product code MTZ

Recent recalls

Product code MTZ

FDA records show no recalls under product code MTZ.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)