Zygomatic Implant System

Implant, Endosseous, Root-form

Southern Implants (Pty) Ltd

The following data is part of a premarket notification filed by Southern Implants (pty) Ltd with the FDA for Zygomatic Implant System.

Pre-market Notification Details

Device IDK173343
510k NumberK173343
Device Name:Zygomatic Implant System
ClassificationImplant, Endosseous, Root-form
Applicant Southern Implants (Pty) Ltd 1 Albert Road Irene,  ZA 0062
ContactLauranda G. Breytenbach
CorrespondentKevin A. Thomas
PaxMed International, LLC 12264 El Camino Real Suite 400 San Diego,  CA  92130
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-24
Decision Date2018-02-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06009544039358 K173343 000
06009544042174 K173343 000
06009544042181 K173343 000
06009544039334 K173343 000
06009544039341 K173343 000
06009544039365 K173343 000
06009544039372 K173343 000
06009544017769 K173343 000
06009544017776 K173343 000
06009544017783 K173343 000
06009544042167 K173343 000
06009544042150 K173343 000
06009544042068 K173343 000
06009544042075 K173343 000
06009544042082 K173343 000
06009544042099 K173343 000
06009544042105 K173343 000
06009544042112 K173343 000
06009544042129 K173343 000
06009544042136 K173343 000
06009544042143 K173343 000
06009544017790 K173343 000
06009544017806 K173343 000
06009544023807 K173343 000
06009544029458 K173343 000
06009544029465 K173343 000
06009544029472 K173343 000
06009544029489 K173343 000
06009544029496 K173343 000
06009544029502 K173343 000
06009544029519 K173343 000
06009544029526 K173343 000
06009544029533 K173343 000
06009544029441 K173343 000
06009544027331 K173343 000
06009544027249 K173343 000
06009544027256 K173343 000
06009544027263 K173343 000
06009544027270 K173343 000
06009544027287 K173343 000
06009544027294 K173343 000
06009544027300 K173343 000
06009544027317 K173343 000
06009544027324 K173343 000
06009544029540 K173343 000

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