SCS DT-02 TRANSVERSE CONNECTOR

Appliance, Fixation, Spinal Interlaminal

ORTHOTEC, L.L.C.

The following data is part of a premarket notification filed by Orthotec, L.l.c. with the FDA for Scs Dt-02 Transverse Connector.

Pre-market Notification Details

Device IDK003823
510k NumberK003823
Device Name:SCS DT-02 TRANSVERSE CONNECTOR
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant ORTHOTEC, L.L.C. 546 HILLGREEN DR. Beverly Hills,  CA  90212 -4110
ContactPatrick Bertranou
CorrespondentPatrick Bertranou
ORTHOTEC, L.L.C. 546 HILLGREEN DR. Beverly Hills,  CA  90212 -4110
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-12-11
Decision Date2001-07-11

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