HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES)

Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Hap Bio-groove Total Hip Prosth (bio-interfaces).

Pre-market Notification Details

Device IDK912370
510k NumberK912370
Device Name:HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES)
ClassificationProsthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Applicant BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw,  IN  46581 -0587
ContactPatricia M Sandborn
CorrespondentPatricia M Sandborn
BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw,  IN  46581 -0587
Product CodeMEH  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-29
Decision Date1991-10-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304069060 K912370 000
00880304069053 K912370 000

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