Elite SPK, Compasso, Elite SPK Kit

Fastener, Fixation, Nondegradable, Soft Tissue

NCS Lab Srl

The following data is part of a premarket notification filed by Ncs Lab Srl with the FDA for Elite Spk, Compasso, Elite Spk Kit.

Pre-market Notification Details

Device IDK160500
510k NumberK160500
Device Name:Elite SPK, Compasso, Elite SPK Kit
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant NCS Lab Srl Via Pola Esterna 4/12 Carpi,  MO  41012
ContactMatteo Mantovani
CorrespondentChristine Brauer
Brauer Device Consultants, LLC 7 Trail House Court Rockville,  MD  20850
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-23
Decision Date2016-04-20
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.