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 |