UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY

Implant, Fixation Device, Spinal

ROSEBURG SA

The following data is part of a premarket notification filed by Roseburg Sa with the FDA for Universal Instrumentation(cd) For Spinal Surgery.

Pre-market Notification Details

Device IDK872715
510k NumberK872715
Device Name:UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY
ClassificationImplant, Fixation Device, Spinal
Applicant ROSEBURG SA SUITE 120 CANAL SQUARE 1054 31ST STREET NW Washington,  DC  20007
ContactDarienne Moyer
CorrespondentDarienne Moyer
ROSEBURG SA SUITE 120 CANAL SQUARE 1054 31ST STREET NW Washington,  DC  20007
Product CodeJDN  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-10
Decision Date1987-12-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.