FULL HEMISPHERE RING-LOC LINER

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Full Hemisphere Ring-loc Liner.

Pre-market Notification Details

Device IDK920640
510k NumberK920640
Device Name:FULL HEMISPHERE RING-LOC LINER
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw,  IN  46581 -0587
ContactDutch Harrison
CorrespondentDutch Harrison
BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw,  IN  46581 -0587
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-02-12
Decision Date1992-06-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304689701 K920640 000

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