FDA product code MTZ: Wrap, Implant, Orbital
MTZ is the FDA product code for wrap, implant, orbital. It is a Class II device, regulated under 21 CFR 886.3320 and reviewed by the Ophthalmic panel. FDA has cleared 2 510(k) submissions under MTZ, from 2 different applicants. The average 510(k) review took 101 days (median 101).
Classification
| Field | Value |
|---|---|
| Device name | Wrap, Implant, Orbital |
| Device class | Class II |
| Regulation | 21 CFR 886.3320 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every MTZ clearance
Top MTZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Macropore Biosurgery, Inc. | 1 | 2003-02-21 |
| Bio-Vascular, Inc. | 1 | 1997-12-16 |
Most recent MTZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K023643 | Macropore Biosurgery, Inc. | MACROPORE SURGICAL BARRIER FILM | 2003-02-21 | 114 |
| K973552 | Bio-Vascular, Inc. | OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP | 1997-12-16 | 88 |
Recalls for MTZ devices
openFDA lists no recalls for product code MTZ.
Frequently asked questions
What is FDA product code MTZ?
MTZ is the FDA product code for wrap, implant, orbital. It is a Class II device, regulated under 21 CFR 886.3320 and reviewed by the Ophthalmic panel.
What device class is MTZ?
Class II, regulation 21 CFR 886.3320. Typical premarket route: 510(k).
How long does a 510(k) take for product code MTZ?
Across 2 cleared submissions the average was 101 days from receipt to decision (median 101).
Which companies have the most MTZ clearances?
Macropore Biosurgery, Inc. (1); Bio-Vascular, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MTZ
- Run a recall and safety report across every MTZ manufacturer
- Watch product code MTZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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