SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO

Appliance, Fixation, Spinal Interlaminal

ORTHOTEC,LLC

The following data is part of a premarket notification filed by Orthotec,llc with the FDA for Scs Claris Spinal System,rextended Omniaxial Connector-,medium, Model Co05, Scs Claris Spinal System,extended Omniaxialo.

Pre-market Notification Details

Device IDK021919
510k NumberK021919
Device Name:SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant ORTHOTEC,LLC 8202 SHERMAN RD. Chesterland,  OH  44026 -2141
ContactKaren E Warden
CorrespondentKaren E Warden
ORTHOTEC,LLC 8202 SHERMAN RD. Chesterland,  OH  44026 -2141
Product CodeKWP  
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-06-11
Decision Date2002-07-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840996122924 K021919 000
00840996122917 K021919 000

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