Ocular Peg
The Ocular Peg is an ophthalmic implant used to couple a motility peg to an orbital implant after enucleation, enabling movement of an ocular prosthesis in synchrony with the fellow eye by integrating the peg with the implant and the prosthesis. Classified as FDA Class 2 under 21 CFR 886.3320 in the Ophthalmic specialty, it requires 510(k) premarket notification. The product code is MQU, and it carries an implant flag.
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Basic Information
- Product Code
- MQU
- Device Class
- FDA class 2
- Regulation Number
- 886.3320
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K000151 | PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE | Apr 10, 2000 | Substantially Equivalent | Integrated Orbital Implants, Inc. |
| K980822 | TITANIUM PEG SYSTEM | Jul 09, 1998 | Substantially Equivalent | Fci Ophthalmics, Inc. |
| K974203 | PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM | Feb 04, 1998 | Substantially Equivalent | Integrated Orbital Implants, Inc. |
| K971583 | MEDPOR OCULAR SCREW AND ACCEOSSORIES | Jun 30, 1997 | Substantially Equivalent | Porex Technologies Corp. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.