The following data is part of a premarket notification filed by Trimed, Inc. with the FDA for Tenodesis Cross Screw, Interference Screw, Suture Bead.
| Device ID | K081348 |
| 510k Number | K081348 |
| Device Name: | TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | TRIMED, INC. 25864 TOURNAMENT RD. SUITE A Valencia, CA 91355 |
| Contact | Kelli Anderson |
| Correspondent | Kelli Anderson TRIMED, INC. 25864 TOURNAMENT RD. SUITE A Valencia, CA 91355 |
| Product Code | MBI |
| Subsequent Product Code | HTY |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-14 |
| Decision Date | 2008-10-17 |
| Summary: | summary |