JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS

Washer, Bolt Nut

BIOMET MANUFACTURING CORP.

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.

Pre-market Notification Details

Device IDK141219
510k NumberK141219
Device Name:JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS
ClassificationWasher, Bolt Nut
Applicant BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw,  IN  46581 -0587
ContactJared Cooper
CorrespondentJared Cooper
BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw,  IN  46581 -0587
Product CodeHTN  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-12
Decision Date2014-07-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304680326 K141219 000
00880304680319 K141219 000

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