IDYS(TM) C

Intervertebral Fusion Device With Bone Graft, Cervical

CLARIANCE

The following data is part of a premarket notification filed by Clariance with the FDA for Idys(tm) C.

Pre-market Notification Details

Device IDK130853
510k NumberK130853
Device Name:IDYS(TM) C
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant CLARIANCE 1835 MARKET STREET 29TH FLOOR Philadelphia,  PA  19103
ContactJanice M Hogan
CorrespondentJanice M Hogan
CLARIANCE 1835 MARKET STREET 29TH FLOOR Philadelphia,  PA  19103
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-28
Decision Date2013-11-13
Summary:summary

NIH GUDID Devices

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