Signature ONE System

Shoulder Arthroplasty Implantation System

Orthosoft Inc. (d/b/a Zimmer CAS)

The following data is part of a premarket notification filed by Orthosoft Inc. (d/b/a Zimmer Cas) with the FDA for Signature One System.

Pre-market Notification Details

Device IDK200615
510k NumberK200615
Device Name:Signature ONE System
ClassificationShoulder Arthroplasty Implantation System
Applicant Orthosoft Inc. (d/b/a Zimmer CAS) 75 Queen Street Suite 3300 Montreal,  CA H3c 2n6
ContactSankalp Dere
CorrespondentSankalp Dere
Orthosoft Inc. (d/b/a Zimmer CAS) 75 Queen Street Suite 3300 Montreal,  CA H3c 2n6
Product CodeQHE  
Subsequent Product CodeKWS
Subsequent Product CodeKWT
Subsequent Product CodeMBF
Subsequent Product CodePHX
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-09
Decision Date2020-06-05

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