OMNIAXIAL CONNECTOR

Orthosis, Spondylolisthesis Spinal Fixation

ORTHOTEC, L.L.C.

The following data is part of a premarket notification filed by Orthotec, L.l.c. with the FDA for Omniaxial Connector.

Pre-market Notification Details

Device IDK993926
510k NumberK993926
Device Name:OMNIAXIAL CONNECTOR
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant ORTHOTEC, L.L.C. 200 GREGORY LN. SUITE C-100 Pleasant Hill,  CA  94523 -3389
ContactDavid W Schlerf
CorrespondentDavid W Schlerf
ORTHOTEC, L.L.C. 200 GREGORY LN. SUITE C-100 Pleasant Hill,  CA  94523 -3389
Product CodeMNH  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-11-18
Decision Date1999-12-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840996122955 K993926 000
00840996122948 K993926 000
00840996122931 K993926 000
00840996122900 K993926 000

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