The following data is part of a premarket notification filed by Ti-mesh, Inc. with the FDA for Timesh Titanium Mini-softplate/screw.
| Device ID | K923802 |
| 510k Number | K923802 |
| Device Name: | TIMESH TITANIUM MINI-SOFTPLATE/SCREW |
| Classification | Plate, Bone |
| Applicant | TI-MESH, INC. 76 SPECTRUM RD. Las Vegas, NV 89101 |
| Contact | Mary R Morgan |
| Correspondent | Mary R 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 | 1992-07-29 |
| Decision Date | 1992-10-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902569227 | K923802 | 000 |