The following data is part of a premarket notification filed by Biomet Sports Medicine, Inc. with the FDA for Peek Knotless Anchors.
| Device ID | K070389 |
| 510k Number | K070389 |
| Device Name: | PEEK KNOTLESS ANCHORS |
| Classification | Screw, Fixation, Bone |
| Applicant | BIOMET SPORTS MEDICINE, INC. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 |
| Contact | Susan Alexander |
| Correspondent | Susan Alexander BIOMET SPORTS MEDICINE, INC. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-09 |
| Decision Date | 2007-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304476394 | K070389 | 000 |
| 00880304470934 | K070389 | 000 |