ORIO-Ti Intervertebral Body Fusion Cage System

Intervertebral Fusion Device With Bone Graft, Cervical

SpineCraft, LLC

The following data is part of a premarket notification filed by Spinecraft, Llc with the FDA for Orio-ti Intervertebral Body Fusion Cage System.

Pre-market Notification Details

Device IDK211935
510k NumberK211935
Device Name:ORIO-Ti Intervertebral Body Fusion Cage System
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant SpineCraft, LLC 777 Oakmont Lane, Suite 200 Westmont,  IL  60559
ContactAmi Akallal-asaad
CorrespondentAmi Akallal-asaad
SpineCraft, LLC 777 Oakmont Lane, Suite 200 Westmont,  IL  60559
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-22
Decision Date2021-09-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00193082121227 K211935 000

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