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 |