The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Timesh Self Drilling Screw.
| Device ID | K062348 |
| 510k Number | K062348 |
| Device Name: | TIMESH SELF DRILLING SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117 |
| Contact | Jeffrey Henderson |
| Correspondent | Jeffrey Henderson MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-11 |
| Decision Date | 2006-09-08 |
| Summary: | summary |