ROSA Hip System

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 Rosa Hip System.

Pre-market Notification Details

Device IDK210998
510k NumberK210998
Device Name:ROSA Hip System
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  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-02
Decision Date2021-08-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024618947 K210998 000
00887868523915 K210998 000
00887868523939 K210998 000
00887868518508 K210998 000
00887868518515 K210998 000
00887868518522 K210998 000
00887868518539 K210998 000
00887868518546 K210998 000
00887868518553 K210998 000
00887868518560 K210998 000
00887868523885 K210998 000
00887868525681 K210998 000
00887868523908 K210998 000

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