SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)

Filler, Bone Void, Calcium Compound

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Calcium Sulfate Bone Void Filler Pellets (synthes Pellets).

Pre-market Notification Details

Device IDK002362
510k NumberK002362
Device Name:SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)
ClassificationFiller, Bone Void, Calcium Compound
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactBonnie J Smith
CorrespondentBonnie J Smith
SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-08-03
Decision Date2000-11-01
Summary:summary

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