OSTEONICS ALUMINA C-TAPER HEAD

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

OSTEONICS CORP.

The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Alumina C-taper Head.

Pre-market Notification Details

Device IDK971409
510k NumberK971409
Device Name:OSTEONICS ALUMINA C-TAPER HEAD
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant OSTEONICS CORP. 59 ROUTE 17 Allendale,  NJ  07401 -1677
ContactKate Sutton
CorrespondentKate Sutton
OSTEONICS CORP. 59 ROUTE 17 Allendale,  NJ  07401 -1677
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-04-16
Decision Date1997-07-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327101249 K971409 000
07613327101188 K971409 000
07613327101171 K971409 000
07613327101164 K971409 000

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