The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Harpoon Suture Anchors.
| Device ID | K943806 |
| 510k Number | K943806 |
| Device Name: | HARPOON SUTURE ANCHORS |
| Classification | Screw, Fixation, Bone |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Mary L Verstynen |
| Correspondent | Mary L Verstynen BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-04 |
| Decision Date | 1995-07-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304404663 | K943806 | 000 |
| 00880304002821 | K943806 | 000 |
| 00880304001145 | K943806 | 000 |
| 00880304000674 | K943806 | 000 |