The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Allthread Peek Anchor With Tantalum Marker.
| Device ID | K071569 |
| 510k Number | K071569 |
| Device Name: | ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Elizabeth Wray |
| Correspondent | Elizabeth Wray BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | MBI |
| Subsequent Product Code | FZP |
| Subsequent Product Code | NEU |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-08 |
| Decision Date | 2007-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304644571 | K071569 | 000 |
| 00880304644564 | K071569 | 000 |