The following data is part of a premarket notification filed by Biomet Sports Medicine with the FDA for Sleeve With Ziploop Fixation Devices.
| Device ID | K101063 |
| 510k Number | K101063 |
| Device Name: | SLEEVE WITH ZIPLOOP FIXATION DEVICES |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | BIOMET SPORTS MEDICINE 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Robert Friddle |
| Correspondent | Robert Friddle BIOMET SPORTS MEDICINE 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-16 |
| Decision Date | 2010-06-23 |
| Summary: | summary |