SYNTHES RESORBABLE CONTOURABLE MESH

Plate, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Resorbable Contourable Mesh.

Pre-market Notification Details

Device IDK022844
510k NumberK022844
Device Name:SYNTHES RESORBABLE CONTOURABLE MESH
ClassificationPlate, Bone
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactMatthew M Hull
CorrespondentMatthew M Hull
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-08-27
Decision Date2003-01-07
Summary:summary

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