The following data is part of a premarket notification filed by Biomet Inc with the FDA for Biomet Headless Compression And Twist-off Screws.
| Device ID | K190035 |
| 510k Number | K190035 |
| Device Name: | Biomet Headless Compression And Twist-Off Screws |
| Classification | Screw, Fixation, Bone |
| Applicant | Biomet Inc 56 East Bell Drive Warsaw, IN 46582 |
| Contact | Andrew Steward |
| Correspondent | Andrew Steward Biomet Inc 56 East Bell Drive Warsaw, IN 46582 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-08 |
| Decision Date | 2019-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868254086 | K190035 | 000 |
| 00887868254079 | K190035 | 000 |