Kentrospine PSS Pedicle Screw System

Thoracolumbosacral Pedicle Screw System

Rivarp Medical Private Limited

The following data is part of a premarket notification filed by Rivarp Medical Private Limited with the FDA for Kentrospine Pss Pedicle Screw System.

Pre-market Notification Details

Device IDK220486
510k NumberK220486
Device Name:Kentrospine PSS Pedicle Screw System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Rivarp Medical Private Limited No.34, Azeez Sait Industrial Town, 6th Mile, Mysore Road,Nayandahalli. Bangalore,  IN 560039
ContactSushma N.R
CorrespondentSushma N.R
Rivarp Medical Private Limited No.34, Azeez Sait Industrial Town, 6th Mile, Mysore Road,Nayandahalli. Bangalore,  IN 560039
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-22
Decision Date2022-07-22

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.