The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for Acid Etched Lag Screws.
| Device ID | K070955 |
| 510k Number | K070955 |
| Device Name: | ACID ETCHED LAG SCREWS |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Beckey Earl |
| Correspondent | Beckey Earl BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-05 |
| Decision Date | 2007-10-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888480269687 | K070955 | 000 |
| 00888480269335 | K070955 | 000 |
| 00888480269328 | K070955 | 000 |
| 00888480269311 | K070955 | 000 |
| 00888480269281 | K070955 | 000 |
| 00888480269274 | K070955 | 000 |
| 00888480269267 | K070955 | 000 |
| 00888480269250 | K070955 | 000 |
| 00888480269236 | K070955 | 000 |
| 00888480269175 | K070955 | 000 |
| 00888480269137 | K070955 | 000 |
| 00888480269342 | K070955 | 000 |
| 00888480269465 | K070955 | 000 |
| 00888480269670 | K070955 | 000 |
| 00888480269663 | K070955 | 000 |
| 00888480269656 | K070955 | 000 |
| 00888480269632 | K070955 | 000 |
| 00888480269625 | K070955 | 000 |
| 00888480269618 | K070955 | 000 |
| 00888480269601 | K070955 | 000 |
| 00888480269571 | K070955 | 000 |
| 00888480269519 | K070955 | 000 |
| 00888480269472 | K070955 | 000 |
| 00888480269120 | K070955 | 000 |