The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Snapshot Fixation System.
| Device ID | K143037 |
| 510k Number | K143037 |
| Device Name: | SnapShot Fixation System |
| Classification | Staple, Fixation, Bone |
| Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Adam Cargill |
| Correspondent | Adam Cargill BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-22 |
| Decision Date | 2015-01-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304685512 | K143037 | 000 |
| 00880304685475 | K143037 | 000 |
| 00887868251061 | K143037 | 000 |
| 00887868251054 | K143037 | 000 |