RESTORATION ADM SYSTEM X3 ACETABULAR

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 Restoration Adm System X3 Acetabular.

Pre-market Notification Details

Device IDK093644
510k NumberK093644
Device Name:RESTORATION ADM SYSTEM X3 ACETABULAR
ClassificationProsthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Applicant HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah,  NJ  07430
ContactAvital Merl Margulies
CorrespondentAvital Merl Margulies
HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah,  NJ  07430
Product CodeMEH  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-11-25
Decision Date2009-12-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04546540665904 K093644 000
04546540638984 K093644 000
04546540638991 K093644 000
04546540639004 K093644 000
04546540639011 K093644 000
04546540639028 K093644 000
04546540639035 K093644 000
04546540639042 K093644 000
04546540639059 K093644 000
04546540638977 K093644 000

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