The following data is part of a premarket notification filed by Depuy Mitek with the FDA for Fastin Rc Anchor.
| Device ID | K060664 |
| 510k Number | K060664 |
| Device Name: | FASTIN RC ANCHOR |
| Classification | Screw, Fixation, Bone |
| Applicant | Depuy Mitek 325 Paramount Drive Raynham, MA 02767 |
| Contact | Ruth Forstadt |
| Correspondent | Ruth Forstadt Depuy Mitek 325 Paramount Drive 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 | 2006-03-13 |
| Decision Date | 2006-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705008254 | K060664 | 000 |
| 10886705008247 | K060664 | 000 |
| 20886705008206 | K060664 | 000 |