Extremity Medical Calcaneal Osteotomy Device

Screw, Fixation, Bone

EXTREMITY MEDICAL, LLC

The following data is part of a premarket notification filed by Extremity Medical, Llc with the FDA for Extremity Medical Calcaneal Osteotomy Device.

Pre-market Notification Details

Device IDK150309
510k NumberK150309
Device Name:Extremity Medical Calcaneal Osteotomy Device
ClassificationScrew, Fixation, Bone
Applicant EXTREMITY MEDICAL, LLC 300 Interpace Pkwy Ste 410 Parsippany,  NJ  07054
ContactBrian Smekal
CorrespondentBrian Smekal
EXTREMITY MEDICAL, LLC 300 Interpace Pkwy Ste 410 Parsippany,  NJ  07054
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-09
Decision Date2015-03-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842078103371 K150309 000
00842078103333 K150309 000

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