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P-K Titanium Motility Peg System

FDA UDI

Class II (US FDA UDI)

by Integrated Orbital Implants, Inc.

Identity

Trade Name
P-K Titanium Motility Peg System FDA UDI
Generic Name
Ocular peg/screw system FDA UDI
Model / Reference
I00051 FDA UDI

Identifiers

Primary DI / UDI-DI
00854066006199 FDA UDI
510(k) Number
K974203 FDA UDI
FDA Product Code
MQU FDA UDI
GMDN Term
Ocular peg/screw system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.3320 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Ocular peg/screw system

P-K Titanium Motility Peg System by Integrated Orbital Implants, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ocular peg/screw system.

Cleared under the same submission

K974203 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integrated Orbital Implants, Inc.

Sources (1)

  • FDA UDI a5062050-a4b5-4f0b-9dc3-a5cf7c7f4482 34 fields · synced Jun 8, 2026