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Platelet And Plasma Separator For Bone Graft Handling

Vertical Spine, LLC

The following data is part of a premarket notification filed by Vertical Spine, Llc with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Food Drugs Medical Devices .

Pre-market Notification Details

Device IDBK120008
510k NumberBK120008
Device Name:510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
ClassificationPlatelet And Plasma Separator For Bone Graft Handling
Applicant Vertical Spine, LLC 2201 Marconi Road Wall,  NJ  07719
Product CodeORG  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-02-24
Decision Date2012-08-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30851802007077 BK120008 0
10850014593633 BK120008 0
10850014593640 BK120008 0
30851802007084 BK120008 0
30851802007008 BK120008 0
30851802007022 BK120008 0
10851802007035 BK120008 0
30851802007046 BK120008 0
30851802007053 BK120008 0
30851802007060 BK120008 0
10850014593626 BK120008 0

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