MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLA
FDA 510(k) clearance K922489 · decided 1992-09-02
Clearance details
- K-number
- K922489
- Device name
- MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLA
- Applicant
- Porex Technologies Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-05-27
- Decision date
- 1992-09-02
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- FWP
- Device class
- 2
- Regulation number
- 878.3550
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Fairburn, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A140 recall (Z-1090-2015) | Stryker Craniomaxillofacial Division | 2015-02-11 |