The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Toggleloc And Juggerloc Implants/instruments/kits.
| Device ID | K141263 |
| 510k Number | K141263 |
| Device Name: | TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS |
| Classification | Staple, Fixation, Bone |
| Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Jared Cooper |
| Correspondent | Jared Cooper BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. 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 | 2014-05-15 |
| Decision Date | 2014-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304857322 | K141263 | 000 |
| 00880304676947 | K141263 | 000 |
| 00880304676930 | K141263 | 000 |
| 00880304676923 | K141263 | 000 |
| 00880304676916 | K141263 | 000 |
| 00880304682757 | K141263 | 000 |
| 00880304682740 | K141263 | 000 |
| 00880304676909 | K141263 | 000 |
| 00887868465758 | K141263 | 000 |
| 00887868526282 | K141263 | 000 |
| 00880304812932 | K141263 | 000 |
| 00880304682894 | K141263 | 000 |
| 00880304682771 | K141263 | 000 |
| 00880304682764 | K141263 | 000 |
| 00880304676893 | K141263 | 000 |
| 00887868569579 | K141263 | 000 |
| 00887868569562 | K141263 | 000 |
| 00887868569555 | K141263 | 000 |
| 00880304676954 | K141263 | 000 |
| 00880304677944 | K141263 | 000 |
| 00880304677951 | K141263 | 000 |
| 00880304857315 | K141263 | 000 |
| 00880304857308 | K141263 | 000 |
| 00880304857292 | K141263 | 000 |
| 00880304857285 | K141263 | 000 |
| 00880304857278 | K141263 | 000 |
| 00880304857261 | K141263 | 000 |
| 00880304812925 | K141263 | 000 |
| 00880304812901 | K141263 | 000 |
| 00880304812895 | K141263 | 000 |
| 00880304812864 | K141263 | 000 |
| 00880304812857 | K141263 | 000 |
| 00880304709829 | K141263 | 000 |
| 00880304683808 | K141263 | 000 |
| 00880304683792 | K141263 | 000 |
| 00880304683778 | K141263 | 000 |
| 00880304677975 | K141263 | 000 |
| 00880304677968 | K141263 | 000 |
| 00887868569548 | K141263 | 000 |