Tailored-H Cervical Stand Alone System

Intervertebral Fusion Device With Integrated Fixation, Cervical

BeSpoke Technologies, LLC

The following data is part of a premarket notification filed by Bespoke Technologies, Llc with the FDA for Tailored-h Cervical Stand Alone System.

Pre-market Notification Details

Device IDK222903
510k NumberK222903
Device Name:Tailored-H Cervical Stand Alone System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant BeSpoke Technologies, LLC 118 S. Cherry St, Suite E Winston-Salemn,  NC  27101
ContactDaniel Hoehn
CorrespondentNathan Wright
BeSpoke Technologies, LLC 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-09-23
Decision Date2022-11-18

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