SYNTHES PATIENT SPECIFIC PLATE

Plate, Bone

SYNTHES INC

The following data is part of a premarket notification filed by Synthes Inc with the FDA for Synthes Patient Specific Plate.

Pre-market Notification Details

Device IDK122647
510k NumberK122647
Device Name:SYNTHES PATIENT SPECIFIC PLATE
ClassificationPlate, Bone
Applicant SYNTHES INC 1301 Goshen Parkway West Chester,  PA  19380
ContactAlan T Haley
CorrespondentAlan T Haley
SYNTHES INC 1301 Goshen Parkway West Chester,  PA  19380
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-30
Decision Date2013-02-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H980SD4801120 K122647 000
H980SD4801110 K122647 000
H980SD4801100 K122647 000
H980SD4801020 K122647 000
H980SD4801010 K122647 000
H980SD4801000 K122647 000

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