NSI HEXED AND NON-HEXED IMPLANT SYSTEM

Implant, Endosseous, Root-form

NSI

The following data is part of a premarket notification filed by Nsi with the FDA for Nsi Hexed And Non-hexed Implant System.

Pre-market Notification Details

Device IDK020617
510k NumberK020617
Device Name:NSI HEXED AND NON-HEXED IMPLANT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant NSI 10565 LEE HIGHWAY SUITE 100 Fairfax,,  VA  22030
ContactGreta M Hols
CorrespondentGreta M Hols
NSI 10565 LEE HIGHWAY SUITE 100 Fairfax,,  VA  22030
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-25
Decision Date2002-05-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06009544001683 K020617 000
06009544001485 K020617 000
06009544001478 K020617 000
06009544001355 K020617 000
06009544001348 K020617 000
06009544001249 K020617 000
06009544001232 K020617 000
06009544001225 K020617 000
06009544001164 K020617 000
06009544001492 K020617 000
06009544001508 K020617 000
06009544001676 K020617 000
06009544001621 K020617 000
06009544001614 K020617 000
06009544001607 K020617 000
06009544001546 K020617 000
06009544001539 K020617 000
06009544001522 K020617 000
06009544001515 K020617 000
06009544001157 K020617 000

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