SYNTHES LOCKING HAND PLATES

Plate, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Locking Hand Plates.

Pre-market Notification Details

Device IDK092247
510k NumberK092247
Device Name:SYNTHES LOCKING HAND PLATES
ClassificationPlate, Fixation, Bone
Applicant SYNTHES (USA) 1301 GOSHEN PKWY. West Chester,  PA  19380
ContactSheri L Musgnung
CorrespondentSheri L Musgnung
SYNTHES (USA) 1301 GOSHEN PKWY. West Chester,  PA  19380
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-07-28
Decision Date2009-09-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H679446355S0 K092247 000
H679447354S0 K092247 000
H679447355S0 K092247 000
H679242531S0 K092247 000
H679247354S0 K092247 000
H679247355S0 K092247 000
H679246354S0 K092247 000
H679246355S0 K092247 000
H679446354S0 K092247 000
H679442531S0 K092247 000

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