The following data is part of a premarket notification filed by Biomet Inc. with the FDA for Titanium Interference Screws.
| Device ID | K193451 |
| 510k Number | K193451 |
| Device Name: | Titanium Interference Screws |
| Classification | Screw, Fixation, Bone |
| Applicant | Biomet Inc. 56 East Bell Drive, PO Box 587 Warsaw, IN 46581 |
| Contact | Saveetha Raghupathi |
| Correspondent | Saveetha Raghupathi Biomet Inc. 56 East Bell Drive, PO Box 587 Warsaw, IN 46581 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-13 |
| Decision Date | 2020-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304412149 | K193451 | 000 |
| 00880304005532 | K193451 | 000 |
| 00880304002791 | K193451 | 000 |
| 00880304002685 | K193451 | 000 |
| 00880304002593 | K193451 | 000 |
| 00880304002579 | K193451 | 000 |
| 00880304002562 | K193451 | 000 |
| 00880304002555 | K193451 | 000 |
| 00880304008458 | K193451 | 000 |
| 00880304008304 | K193451 | 000 |
| 00880304008311 | K193451 | 000 |
| 00880304008465 | K193451 | 000 |
| 00880304412118 | K193451 | 000 |
| 00880304412101 | K193451 | 000 |
| 00880304412071 | K193451 | 000 |
| 00880304412040 | K193451 | 000 |
| 00880304412026 | K193451 | 000 |
| 00880304412002 | K193451 | 000 |
| 00880304411999 | K193451 | 000 |
| 00880304411937 | K193451 | 000 |
| 00880304412132 | K193451 | 000 |