The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Juggerloc Bone To Bone Implants/ Bone Instruments/ Bone Implant And Instrument Kits.
| Device ID | K141219 |
| 510k Number | K141219 |
| Device Name: | JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS |
| Classification | Washer, Bolt Nut |
| 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 | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-12 |
| Decision Date | 2014-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304680326 | K141219 | 000 |
| 00880304680319 | K141219 | 000 |