The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Toggleloc Xtender; Toggleloc Xl; Implant Kit Toggleloc; Implant Kit Toggleloc Btb, Extended Toggleloc; Toggleloc; Btb To.
| Device ID | K130033 |
| 510k Number | K130033 |
| Device Name: | TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Elizabeth Wray |
| Correspondent | Elizabeth Wray BIOMET MANUFACTURING CORP. 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 | 2013-01-04 |
| Decision Date | 2013-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304863422 | K130033 | 000 |
| 00880304567658 | K130033 | 000 |
| 00880304567641 | K130033 | 000 |
| 00880304567634 | K130033 | 000 |
| 00880304478923 | K130033 | 000 |
| 00880304476097 | K130033 | 000 |
| 00880304464773 | K130033 | 000 |