SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR COMPONENTS/MODULAR HEADS/CENTRALIZERS

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 Shp Hip System-femoral Components/acetabular Components/modular Heads/centralizers.

Pre-market Notification Details

Device IDK960984
510k NumberK960984
Device Name:SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR COMPONENTS/MODULAR HEADS/CENTRALIZERS
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
ContactPatricia Sandborn Beres
CorrespondentPatricia Sandborn Beres
BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw,  IN  46581 -0587
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-03-11
Decision Date1996-09-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304255593 K960984 000
00880304255494 K960984 000
00880304255500 K960984 000
00880304255517 K960984 000
00880304255524 K960984 000
00880304255531 K960984 000
00880304255548 K960984 000
00880304255555 K960984 000
00880304255579 K960984 000
00880304255586 K960984 000
00880304255487 K960984 000

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