PriMatrix Dermal Repair Scaffold
FDA 510(k) clearance K153690 · decided 2016-02-22
Clearance details
- K-number
- K153690
- Device name
- PriMatrix Dermal Repair Scaffold
- Applicant
- Tei Biosciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-12-23
- Decision date
- 2016-02-22
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- KGN
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Boston, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, recall (Z-2077-2023) | TEI Biosciences, Inc. | 2024-09-30 |
| PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm recall (Z-2078-2023) | TEI Biosciences, Inc. | 2024-09-30 |
| PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 recall (Z-2079-2023) | TEI Biosciences, Inc. | 2024-09-30 |