ZODIAC SPINAL FIXATION SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

ALPHATEC/NEXMED

The following data is part of a premarket notification filed by Alphatec/nexmed with the FDA for Zodiac Spinal Fixation System.

Pre-market Notification Details

Device IDK051286
510k NumberK051286
Device Name:ZODIAC SPINAL FIXATION SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant ALPHATEC/NEXMED 6110 CORTE DEL CEDRO Carlsbad,  CA  92009
ContactEllen A Yarnall
CorrespondentEllen A Yarnall
ALPHATEC/NEXMED 6110 CORTE DEL CEDRO Carlsbad,  CA  92009
Product CodeMNH  
Subsequent Product CodeKWP
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-05-18
Decision Date2005-06-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00844856069022 K051286 000
00844856069015 K051286 000
00844856069008 K051286 000
00844856068995 K051286 000
00844856068988 K051286 000
00844856068971 K051286 000
00844856068964 K051286 000
00844856057500 K051286 000
00844856057494 K051286 000

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