ONE Planner Hip

System, Image Processing, Radiological

Orthosoft D/b/a Zimmer CAS

The following data is part of a premarket notification filed by Orthosoft D/b/a Zimmer Cas with the FDA for One Planner Hip.

Pre-market Notification Details

Device IDK210653
510k NumberK210653
Device Name:ONE Planner Hip
ClassificationSystem, Image Processing, Radiological
Applicant Orthosoft D/b/a Zimmer CAS 75 Queen Street, Suite 3300 Montreal,  CA H3c 2n6
ContactPaul Hardy
CorrespondentPaul Hardy
Orthosoft D/b/a Zimmer CAS 75 Queen Street, Suite 3300 Montreal,  CA H3c 2n6
Product CodeLLZ  
Subsequent Product CodeLPH
Subsequent Product CodeLZO
Subsequent Product CodePBI
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-04
Decision Date2021-07-07

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.