SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06

Orthosis, Spinal Pedicle Fixation

ORTHO TEC LLC

The following data is part of a premarket notification filed by Ortho Tec Llc with the FDA for Scs Claris Spinal System, Lengthened Lateral Connector, Model Al06.

Pre-market Notification Details

Device IDK021379
510k NumberK021379
Device Name:SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant ORTHO TEC LLC 8202 SHERMAN RD. Chesterland,  OH  44026 -2141
ContactKaren E Warden
CorrespondentKaren E Warden
ORTHO TEC LLC 8202 SHERMAN RD. Chesterland,  OH  44026 -2141
Product CodeMNI  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-01
Decision Date2002-05-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840996174695 K021379 000
00840996174404 K021379 000
00840996163675 K021379 000
00840996163668 K021379 000
00840996122894 K021379 000
00840996122887 K021379 000
00840996122870 K021379 000
00840996122863 K021379 000
00840996122856 K021379 000

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