The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Biomet Bone Screw.
| Device ID | K964970 |
| 510k Number | K964970 |
| Device Name: | BIOMET BONE SCREW |
| 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 (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-12 |
| Decision Date | 1997-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304424470 | K964970 | 000 |
| 00880304424302 | K964970 | 000 |
| 00880304424296 | K964970 | 000 |
| 00880304424289 | K964970 | 000 |
| 00880304419582 | K964970 | 000 |
| 00880304419575 | K964970 | 000 |
| 00880304419568 | K964970 | 000 |
| 00880304419551 | K964970 | 000 |
| 00880304419544 | K964970 | 000 |
| 00880304419537 | K964970 | 000 |
| 00880304419520 | K964970 | 000 |
| 00880304419513 | K964970 | 000 |
| 00880304419506 | K964970 | 000 |
| 00880304419490 | K964970 | 000 |
| 00880304424319 | K964970 | 000 |
| 00880304424326 | K964970 | 000 |
| 00880304424333 | K964970 | 000 |
| 00880304424463 | K964970 | 000 |
| 00880304424456 | K964970 | 000 |
| 00880304424449 | K964970 | 000 |
| 00880304424432 | K964970 | 000 |
| 00880304424425 | K964970 | 000 |
| 00880304424418 | K964970 | 000 |
| 00880304424401 | K964970 | 000 |
| 00880304424395 | K964970 | 000 |
| 00880304424388 | K964970 | 000 |
| 00880304424371 | K964970 | 000 |
| 00880304424364 | K964970 | 000 |
| 00880304424357 | K964970 | 000 |
| 00880304424340 | K964970 | 000 |
| 05019279506064 | K964970 | 000 |