The following data is part of a premarket notification filed by Tei Biosciences Inc. with the FDA for Orthomend.
| Device ID | K031188 |
| 510k Number | K031188 |
| Device Name: | ORTHOMEND |
| Classification | Mesh, Surgical, Polymeric |
| 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 | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-15 |
| Decision Date | 2003-06-27 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ORTHOMEND 97271990 not registered Live/Pending |
Creative Medical Technologies Inc. 2022-02-17 |
![]() ORTHOMEND 75397080 not registered Dead/Abandoned |
Walker, Robert Terry 1997-11-28 |