PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM
FDA 510(k) clearance K974203 · decided 1998-02-04
Clearance details
- K-number
- K974203
- Device name
- PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM
- Applicant
- Integrated Orbital Implants, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-11-10
- Decision date
- 1998-02-04
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- MQU
- Device class
- 2
- Regulation number
- 886.3320
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE (K000151) | Integrated Orbital Implants, Inc. | 2000-04-10 |
| TITANIUM PEG SYSTEM (K980822) | Fci Ophthalmics, Inc. | 1998-07-09 |
| MEDPOR OCULAR SCREW AND ACCEOSSORIES (K971583) | Porex Technologies Corp. | 1997-06-30 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Perry-Kolberg Titanium Motility/Support System (Threaded Sleeve and Flat Peg), Model Numbe recall (Z-0396-2007) | Integrated Orbital Implants Inc | 2007-02-07 |