Perry-Kolberg (PK) Ha-Coated Titanium Sleeve
FDA 510(k) K000151 · Integrated Orbital Implants, Inc.
510(k) numberK000151
Submission
- Device name
- Perry-Kolberg (PK) Ha-Coated Titanium Sleeve
- Applicant
- Integrated Orbital Implants, Inc.
San Diego, CA, US - Received
- January 19, 2000
- Decision date
- April 10, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQU – Ocular Peg
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3320
- Specialty
- Ophthalmic
- Implant
- Yes
Other 510(k)s with product code MQU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K980822 | Titanium Peg SystemMQU · Traditional | Fci Ophthalmics, Inc. | 07/09/1998SE |
| K974203 | Perry-Kolberg (PK) Titanium Motility/Support SystemMQU · Traditional | Integrated Orbital Implants, Inc. | 02/04/1998SE |
| K971583 | Medpor Ocular Screw and AcceossoriesMQU · Traditional | Porex Technologies Corp. | 06/30/1997SE |
More from Porex Technologies Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K003338 | Bio-Eye II Orbital ImplantHPZ · Traditional | 02/07/2001SE |
| K982562 | Bio-Eye Hydroxyapatite Ocular Impland and ConformerHPZ · Traditional | 12/28/1998SE |
| K974203 | Perry-Kolberg (PK) Titanium Motility/Support SystemMQU · Traditional | 02/04/1998SE |
| K891137 | Motility Orbital ImplantHPZ · Traditional | 08/24/1989SE |
Questions and answers
When was Perry-Kolberg (PK) Ha-Coated Titanium Sleeve cleared by the FDA?
Perry-Kolberg (PK) Ha-Coated Titanium Sleeve (K000151) received a 510(k) decision of Substantially Equivalent on April 10, 2000, 82 days after the submission was received.
What is the product code of K000151?
The FDA product code is MQU – Ocular Peg, a Class II (moderate risk) device regulated under 21 CFR 886.3320.