SYNTHES (USA) CALVICLE HOOK PLATE

Plate, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Calvicle Hook Plate.

Pre-market Notification Details

Device IDK031677
510k NumberK031677
Device Name:SYNTHES (USA) CALVICLE HOOK PLATE
ClassificationPlate, Fixation, Bone
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactBonnie J Smith
CorrespondentBonnie J Smith
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-05-30
Decision Date2003-08-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H6794410690 K031677 000
H6792410630 K031677 000
H6792410640 K031677 000
H6792410650 K031677 000
H6792410660 K031677 000
H6792410670 K031677 000
H6792410680 K031677 000
H6792410690 K031677 000
H6794410620 K031677 000
H6794410630 K031677 000
H6794410640 K031677 000
H6794410650 K031677 000
H6794410660 K031677 000
H6794410670 K031677 000
H6794410680 K031677 000
H6792410620 K031677 000

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