The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Harpoon Suture Anchors.
| Device ID | K973775 |
| 510k Number | K973775 |
| Device Name: | HARPOON SUTURE ANCHORS |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Mary Verstynen |
| Correspondent | Mary Verstynen BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-03 |
| Decision Date | 1998-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304465541 | K973775 | 000 |
| 00880304464810 | K973775 | 000 |
| 00880304430952 | K973775 | 000 |
| 00880304430945 | K973775 | 000 |