PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD
FDA 510(k) clearance K100261 · decided 2010-12-10
Clearance details
- K-number
- K100261
- Device name
- PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD
- Applicant
- Tei Biosciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-01-28
- Decision date
- 2010-12-10
- Days to decision
- 316 days
- Clearance type
- Abbreviated
- Product code
- FRO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Boston, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, recall (Z-2080-2023) | TEI Biosciences, Inc. | 2024-09-30 |
| PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 c recall (Z-2081-2023) | TEI Biosciences, Inc. | 2024-09-30 |
| PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1) recall (Z-2082-2023) | TEI Biosciences, Inc. | 2024-09-30 |