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 |