The following data is part of a premarket notification filed by Biomet Sports Medicine, Inc. with the FDA for Harpoon Suture Anchor.
| Device ID | K071816 |
| 510k Number | K071816 |
| Device Name: | HARPOON SUTURE ANCHOR |
| Classification | Screw, Fixation, Bone |
| Applicant | BIOMET SPORTS MEDICINE, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Elizabeth Wray |
| Correspondent | Elizabeth Wray BIOMET SPORTS MEDICINE, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HWC |
| Subsequent Product Code | JDR |
| Subsequent Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-02 |
| Decision Date | 2007-09-20 |
| Summary: | summary |