ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite

Pin, Fixation, Threaded

CITIEFFE S.r.l

The following data is part of a premarket notification filed by Citieffe S.r.l with the FDA for St.a.r. 90 F4 External Fixation Screws With Hydroxyapatite.

Pre-market Notification Details

Device IDK150661
510k NumberK150661
Device Name:ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite
ClassificationPin, Fixation, Threaded
Applicant CITIEFFE S.r.l Via Armaroli 21 Calderara Di Reno,  IT 400012
ContactStefano Pullega
CorrespondentMarisa Testa
Thema S.r.l. Via Saragat 5 Imola,  IT 40026
Product CodeJDW  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-13
Decision Date2015-07-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08056711920061 K150661 000
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B56211701256150S00 K150661 000
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B56211701360198S00 K150661 000
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B56211701360178S00 K150661 000
B56211701360150S00 K150661 000
08032909624690 K150661 000

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