PORCINE SURGICAL MESH; DERMAL MATRIX
FDA 510(k) clearance K081272 · decided 2008-07-31
Clearance details
- K-number
- K081272
- Device name
- PORCINE SURGICAL MESH; DERMAL MATRIX
- Applicant
- Brennen Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2008-05-05
- Decision date
- 2008-07-31
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- FTM
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 10 x 15 cm Rectangle Catalog #: 11 recall (Z-1379-2011) | Davol, Inc., Sub. C. R. Bard, Inc. | 2011-03-02 |
| XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 15 x 20 cm Rectangle Catalog #: 11 recall (Z-1380-2011) | Davol, Inc., Sub. C. R. Bard, Inc. | 2011-03-02 |
| XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 19 x 28 cm Rectangle Catalog #: 11 recall (Z-1381-2011) | Davol, Inc., Sub. C. R. Bard, Inc. | 2011-03-02 |
| XenMatrix Surgical Graft ,Sterile, Porcine Dermal Matrix 19 x 35 cm Rectangle Catalog #: 1 recall (Z-1382-2011) | Davol, Inc., Sub. C. R. Bard, Inc. | 2011-03-02 |