The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Bone Mulch Screw System.
| Device ID | K991298 |
| 510k Number | K991298 |
| Device Name: | BONE MULCH SCREW SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Fred Mcclure |
| Correspondent | Fred Mcclure BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-15 |
| Decision Date | 1999-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304508286 | K991298 | 000 |
| 00880304471290 | K991298 | 000 |
| 00880304470514 | K991298 | 000 |
| 00880304116511 | K991298 | 000 |
| 00887868228131 | K991298 | 000 |
| 00887868228124 | K991298 | 000 |
| 00887868228117 | K991298 | 000 |