ORTHOMEND SOFT TISSUE MATRIX
FDA 510(k) clearance K071807 · decided 2007-08-06
Clearance details
- K-number
- K071807
- Device name
- ORTHOMEND SOFT TISSUE MATRIX
- Applicant
- Tei Biosciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-07-02
- Decision date
- 2007-08-06
- Days to decision
- 35 days
- Clearance type
- Special
- Product code
- FTM
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Boston, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 recall (Z-2069-2023) | TEI Biosciences, Inc. | 2024-09-30 |
| SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Sem recall (Z-2070-2023) | TEI Biosciences, Inc. | 2024-09-30 |
| SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thi recall (Z-2071-2023) | TEI Biosciences, Inc. | 2024-09-30 |
| Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, recall (Z-2083-2023) | TEI Biosciences, Inc. | 2024-09-30 |