The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Composite Hitch Suture Anchor.
Device ID | K081172 |
510k Number | K081172 |
Device Name: | COMPOSITE HITCH SUTURE ANCHOR |
Classification | Staple, Fixation, Bone |
Applicant | BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587 |
Contact | Becky Earl |
Correspondent | Becky Earl BIOMET MANUFACTURING CORP. PO 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 | 2008-04-24 |
Decision Date | 2008-07-17 |
Summary: | summary |