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 |