Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart D — Prosthetic Devices](/submissions/OP/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 886.3320](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/886.3320) → MTZ — Wrap, Implant, Orbital

# MTZ · Wrap, Implant, Orbital

_Ophthalmic · 21 CFR 886.3320 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MTZ

## Overview

- **Product Code:** MTZ
- **Device Name:** Wrap, Implant, Orbital
- **Regulation:** [21 CFR 886.3320](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/886.3320)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **Implant:** yes

## Identification

An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.

## Classification Rationale

Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

## Special Controls

*Classification.* Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K023643](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MTZ/K023643.md) | MACROPORE SURGICAL BARRIER FILM | Macropore Biosurgery, Inc. | Feb 21, 2003 | SESE |
| [K973552](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MTZ/K973552.md) | OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP | Bio-Vascular, Inc. | Dec 16, 1997 | SESE |

## Top Applicants

- Bio-Vascular, Inc. — 1 clearance
- Macropore Biosurgery, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MTZ](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MTZ)

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