The following data is part of a premarket notification filed by Tei Biosciences Inc. with the FDA for Orthomend Soft Tissue Matrix.
| Device ID | K071807 |
| 510k Number | K071807 |
| Device Name: | ORTHOMEND SOFT TISSUE MATRIX |
| Classification | Mesh, Surgical |
| Applicant | TEI BIOSCIENCES INC. 7 ELKINS ST. Boston, MA 02127 |
| Contact | Kenneth James |
| Correspondent | Kenneth James TEI BIOSCIENCES INC. 7 ELKINS ST. Boston, MA 02127 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-02 |
| Decision Date | 2007-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780112815 | K071807 | 000 |
| 10381780112662 | K071807 | 000 |
| 10381780112679 | K071807 | 000 |
| 10381780112686 | K071807 | 000 |
| 10381780112693 | K071807 | 000 |
| 10381780112709 | K071807 | 000 |
| 10381780112716 | K071807 | 000 |
| 10381780112723 | K071807 | 000 |
| 10381780112730 | K071807 | 000 |
| 10381780112747 | K071807 | 000 |
| 10381780112754 | K071807 | 000 |
| 10381780112761 | K071807 | 000 |
| 10381780112778 | K071807 | 000 |
| 10381780112785 | K071807 | 000 |
| 10381780112792 | K071807 | 000 |
| 10381780112808 | K071807 | 000 |
| 10381780112655 | K071807 | 000 |