SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS

Mesh, Surgical

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Porous Polyethylene Implants.

Pre-market Notification Details

Device IDK051879
510k NumberK051879
Device Name:SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS
ClassificationMesh, Surgical
Applicant SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester,  PA  19380
ContactKathy Anderson
CorrespondentKathy Anderson
SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester,  PA  19380
Product CodeFTM  
Subsequent Product CodeFTL
Subsequent Product CodeGWO
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-07-11
Decision Date2005-10-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H98008520231S0 K051879 000
H98008510545S0 K051879 000
H98008510544S0 K051879 000
H98008510543S0 K051879 000
H98008510542S0 K051879 000
H98008510541S0 K051879 000
H98008510540S0 K051879 000
H98008510220S0 K051879 000
H98008510140S0 K051879 000
H98008510130S0 K051879 000
H98008510120S0 K051879 000
H98008510546S0 K051879 000
H98008510547S0 K051879 000
H98008510640S0 K051879 000
H98008520230S0 K051879 000
H98008520221S0 K051879 000
H98008520220S0 K051879 000
H98008520131S0 K051879 000
H98008520130S0 K051879 000
H98008520121S0 K051879 000
H98008520120S0 K051879 000
H98008510646S0 K051879 000
H98008510642S0 K051879 000
H98008510641S0 K051879 000
H98008510110S0 K051879 000

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