ZODIAC SPINAL FIXATION SYSTEM

Appliance, Fixation, Spinal Interlaminal

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 IDK050830
510k NumberK050830
Device Name:ZODIAC SPINAL FIXATION SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
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 CodeKWP  
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-04-01
Decision Date2005-06-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00844856069404 K050830 000
00844856031739 K050830 000
00844856031746 K050830 000
00844856031753 K050830 000
00844856031760 K050830 000
00844856057517 K050830 000
00844856069367 K050830 000
00844856069374 K050830 000
00844856069381 K050830 000
00844856069398 K050830 000
00844856031722 K050830 000

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