SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES

Plate, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Sterile Low Profile Neuro Contourable Mesh Plates.

Pre-market Notification Details

Device IDK033160
510k NumberK033160
Device Name:SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES
ClassificationPlate, Bone
Applicant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
ContactLisa M Boyle
CorrespondentLisa M Boyle
SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-30
Decision Date2003-10-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H980421547S0 K033160 000
H980421532S0 K033160 000
H980421533S0 K033160 000
H980421534S0 K033160 000
H980421535S0 K033160 000
H980421536S0 K033160 000
H980421537S0 K033160 000
H980421538S0 K033160 000
H980421539S0 K033160 000
H980421540S0 K033160 000
H980421541S0 K033160 000
H980421542S0 K033160 000
H980421543S0 K033160 000
H980421544S0 K033160 000
H980421545S0 K033160 000
H980421546S0 K033160 000
H980421531S0 K033160 000

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