510(k) K071807 ยท FTM Mesh, Surgical
ORTHOMEND SOFT TISSUE MATRIX
| Applicant | Tei Biosciences, Inc., Boston MA, US |
| Decision | Substantially Equivalent, Aug 6, 2007 |
| Received | Jul 2, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071807
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2024 | TEI Biosciences, Inc. SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x15 cm, 1.0 10x20 cm, 1.0 16x20 cm, 1.0 13x25 cm, 1.0 4x16 cm, 1.0 3x3 cm, 1.0 4x Open, Classified |
FTM | None listed |
| Sep 30, 2024 | TEI Biosciences, Inc. SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval, 15x15 cm Semi-Oval, 8x20 cm Fenestrated, Open, Classified |
FTM | None listed |
| Sep 30, 2024 | TEI Biosciences, Inc. SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin. Open, Classified |
FTM | None listed |
| Sep 30, 2024 | TEI Biosciences, Inc. Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm. Open, Classified |
FTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.