The following data is part of a premarket notification filed by Biomet Sports Medicine with the FDA for Toggleloc System.
| Device ID | K083070 |
| 510k Number | K083070 |
| Device Name: | TOGGLELOC SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | BIOMET SPORTS MEDICINE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Robert Friddle |
| Correspondent | Robert Friddle BIOMET SPORTS MEDICINE 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 | 2008-10-15 |
| Decision Date | 2008-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304979598 | K083070 | 000 |
| 00887868572548 | K083070 | 000 |
| 00880304470361 | K083070 | 000 |
| 00880304472709 | K083070 | 000 |
| 00880304473560 | K083070 | 000 |
| 00880304475854 | K083070 | 000 |
| 00880304476103 | K083070 | 000 |
| 00880304478404 | K083070 | 000 |
| 00880304478824 | K083070 | 000 |
| 00880304979581 | K083070 | 000 |
| 00887868572531 | K083070 | 000 |