DALI SPINAL FIXATION SYSTEM

Thoracolumbosacral Pedicle Screw System

ACCEL SPINE

The following data is part of a premarket notification filed by Accel Spine with the FDA for Dali Spinal Fixation System.

Pre-market Notification Details

Device IDK121568
510k NumberK121568
Device Name:DALI SPINAL FIXATION SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant ACCEL SPINE 14850 Quorum Dr Ste 220 Dallas,  TX  75254
ContactDaniel Chon
CorrespondentDaniel Chon
ACCEL SPINE 14850 Quorum Dr Ste 220 Dallas,  TX  75254
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-29
Decision Date2012-09-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841732128309 K121568 000
00841732121362 K121568 000
00841732121379 K121568 000
00841732121386 K121568 000
00841732142961 K121568 000
00841732142978 K121568 000
00841732142985 K121568 000
00841732142992 K121568 000
00841732143005 K121568 000
00841732125209 K121568 000
00841732128255 K121568 000
00841732128286 K121568 000
00841732128293 K121568 000
00841732121355 K121568 000

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