PHANTOM PLUS CAGE SYSTEM

Intervertebral Fusion Device With Bone Graft, Cervical

US SPINE

The following data is part of a premarket notification filed by Us Spine with the FDA for Phantom Plus Cage System.

Pre-market Notification Details

Device IDK082801
510k NumberK082801
Device Name:PHANTOM PLUS CAGE SYSTEM
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant US SPINE 3600 FAU BLVD. SUITE 101 Boca Raton,  FL  33431
ContactPeter Harris
CorrespondentPeter Harris
US SPINE 3600 FAU BLVD. SUITE 101 Boca Raton,  FL  33431
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-24
Decision Date2008-12-22
Summary:summary

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