The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Tithon Staple With Osseoti Technology.
| Device ID | K151615 |
| 510k Number | K151615 |
| Device Name: | TiTHON Staple With OsseoTi Technology |
| Classification | Staple, Fixation, Bone |
| Applicant | BIOMET MANUFACTURING CORP. 56 BELL DRIVE Warsaw, IN 46580 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET MANUFACTURING CORP. 56 BELL DRIVE Warsaw, IN 46580 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-15 |
| Decision Date | 2015-10-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304806412 | K151615 | 000 |
| 00880304806405 | K151615 | 000 |
| 00880304806399 | K151615 | 000 |
| 00880304806382 | K151615 | 000 |
| 00880304806375 | K151615 | 000 |
| 00880304806368 | K151615 | 000 |
| 00880304806351 | K151615 | 000 |
| 00880304806344 | K151615 | 000 |
| 00880304806337 | K151615 | 000 |