TRANS1 FACET SCREW

System, Facet Screw Spinal Device

TRANS1 INCORPORATED

The following data is part of a premarket notification filed by Trans1 Incorporated with the FDA for Trans1 Facet Screw.

Pre-market Notification Details

Device IDK073515
510k NumberK073515
Device Name:TRANS1 FACET SCREW
ClassificationSystem, Facet Screw Spinal Device
Applicant TRANS1 INCORPORATED 411 LANDMARK DR. Wilmington,  NC  28412
ContactWilliam Jackson
CorrespondentWilliam Jackson
TRANS1 INCORPORATED 411 LANDMARK DR. Wilmington,  NC  28412
Product CodeMRW  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical Specialty510(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
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-14
Decision Date2008-03-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815361020679 K073515 000
00815361020600 K073515 000
00815361020266 K073515 000
00815361020259 K073515 000
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00815361020600 K073515 000
00815361020266 K073515 000
00815361020259 K073515 000
00815361020242 K073515 000
00815361020617 K073515 000
00815361020624 K073515 000
00815361020662 K073515 000
00815361020655 K073515 000
00815361020648 K073515 000
00815361020631 K073515 000
00815361020624 K073515 000
00815361020617 K073515 000
00815361020600 K073515 000
00815361020266 K073515 000
00815361020259 K073515 000
00815361020242 K073515 000
00815361020235 K073515 000
00815361020679 K073515 000
00815361020662 K073515 000
00815361020655 K073515 000
00815361020648 K073515 000
00815361020631 K073515 000
00815361020235 K073515 000

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