The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Bone Mulch Screw.
| Device ID | K941941 |
| 510k Number | K941941 |
| Device Name: | BONE MULCH SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46580 |
| Contact | Mary L Verstynen |
| Correspondent | Mary L Verstynen BIOMET, INC. P.O. BOX 587 Warsaw, IN 46580 |
| 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 | 1994-04-21 |
| Decision Date | 1995-02-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304411302 | K941941 | 000 |
| 00880304411296 | K941941 | 000 |
| 00880304411289 | K941941 | 000 |
| 00880304409057 | K941941 | 000 |
| 00880304409033 | K941941 | 000 |
| 00880304409019 | K941941 | 000 |
| 00880304408982 | K941941 | 000 |
| 00880304408975 | K941941 | 000 |