MEDPOR PTERIONAL SURGICAL IMPLANT
FDA 510(k) clearance K002586 · decided 2000-11-17
Clearance details
- K-number
- K002586
- Device name
- MEDPOR PTERIONAL SURGICAL IMPLANT
- Applicant
- Porex Surgical Products Group
- Decision
- Substantially Equivalent
- Date received
- 2000-08-21
- Decision date
- 2000-11-17
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- MNF
- Device class
- 2
- Regulation number
- 878.3550
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Newnan, GA, 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 |
|---|---|---|
| OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT (K111069) | Osteosymbionics, LLC | 2011-09-22 |
Recalls involving this device
No recalls on record reference this clearance.