The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Spiralok Anchor.
Device ID | K060271 |
510k Number | K060271 |
Device Name: | SPIRALOK ANCHOR |
Classification | Screw, Fixation, Bone |
Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
Contact | Ruth Forstadt |
Correspondent | Ruth Forstadt DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-02-01 |
Decision Date | 2006-05-04 |
Summary: | summary |