OSTEONICS(R) CCR HIP STEM SERIES

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

OSTEONICS CORP.

The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics(r) Ccr Hip Stem Series.

Pre-market Notification Details

Device IDK945574
510k NumberK945574
Device Name:OSTEONICS(R) CCR HIP STEM SERIES
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant OSTEONICS CORP. 59 ROUTE 17 Allendale,  NJ  07401 -1677
ContactRobert A Koch
CorrespondentRobert A Koch
OSTEONICS CORP. 59 ROUTE 17 Allendale,  NJ  07401 -1677
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-14
Decision Date1995-05-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327021967 K945574 000
07613327021943 K945574 000
07613327021936 K945574 000
07613327021929 K945574 000
07613327021912 K945574 000
07613327021905 K945574 000
07613327021875 K945574 000

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