NOVEL FIT AND FILL STEM

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

HOWMEDICA OSTEONICS CORP

The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Novel Fit And Fill Stem.

Pre-market Notification Details

Device IDK122853
510k NumberK122853
Device Name:NOVEL FIT AND FILL STEM
ClassificationProsthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Applicant HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah,  NJ  07430
ContactValerie Giambanco
CorrespondentValerie Giambanco
HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah,  NJ  07430
Product CodeMEH  
Subsequent Product CodeJDI
Subsequent Product CodeKWL
Subsequent Product CodeKWY
Subsequent Product CodeKWZ
Subsequent Product CodeLPH
Subsequent Product CodeLWJ
Subsequent Product CodeLZO
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-18
Decision Date2013-02-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327311570 K122853 000
07613327311501 K122853 000
07613327311495 K122853 000
07613327311198 K122853 000
07613327310252 K122853 000
07613327310160 K122853 000
07613327310115 K122853 000

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