The following data is part of a premarket notification filed by Ti-mesh, Inc. with the FDA for Tismesh System.
| Device ID | K923419 |
| 510k Number | K923419 |
| Device Name: | TISMESH SYSTEM |
| Classification | Plate, Bone |
| Applicant | TI-MESH, INC. 76 SPECTRUM RD. Las Vegas, NV 89101 |
| Contact | Mary P Morgan |
| Correspondent | Mary P Morgan TI-MESH, INC. 76 SPECTRUM RD. Las Vegas, NV 89101 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-13 |
| Decision Date | 1993-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902973048 | K923419 | 000 |
| 00721902973024 | K923419 | 000 |
| 00721902525476 | K923419 | 000 |