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) → MQU — Ocular Peg

# MQU · Ocular Peg

_Ophthalmic · 21 CFR 886.3320 · Class 2_

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

## Overview

- **Product Code:** MQU
- **Device Name:** Ocular Peg
- **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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K000151](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MQU/K000151.md) | PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE | Integrated Orbital Implants, Inc. | Apr 10, 2000 | SESE |
| [K980822](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MQU/K980822.md) | TITANIUM PEG SYSTEM | Fci Ophthalmics, Inc. | Jul 9, 1998 | SESE |
| [K974203](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MQU/K974203.md) | PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM | Integrated Orbital Implants, Inc. | Feb 4, 1998 | SESE |
| [K971583](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/MQU/K971583.md) | MEDPOR OCULAR SCREW AND ACCEOSSORIES | Porex Technologies Corp. | Jun 30, 1997 | SESE |

## Top Applicants

- Integrated Orbital Implants, Inc. — 2 clearances
- Fci Ophthalmics, Inc. — 1 clearance
- Porex Technologies Corp. — 1 clearance

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

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