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 | K041069 |
| 510k Number | K041069 |
| Device Name: | SPIRALOK ANCHOR |
| Classification | Screw, Fixation, Bone |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVE. Norwood, MA 02062 |
| Contact | Karen Sylvia |
| Correspondent | Karen Sylvia DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVE. Norwood, MA 02062 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-26 |
| Decision Date | 2004-11-09 |
| Summary: | summary |