Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System

Intervertebral Fusion Device With Bone Graft, Cervical

Meditech Spine, LLC

The following data is part of a premarket notification filed by Meditech Spine, Llc with the FDA for Talos®-c Cervical Intervertebral Body Fusion System, Talos®-c (ha) Cervical Intervertebral Body Fusion System.

Pre-market Notification Details

Device IDK201506
510k NumberK201506
Device Name:Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant Meditech Spine, LLC 1447 Peachtree St NE Suite 440 Atlanta,  GA  30309
ContactBruce Dunaway
CorrespondentBruce Dunaway
Meditech Spine, LLC 1447 Peachtree St NE Suite 440 Atlanta,  GA  30309
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-05
Decision Date2020-09-11

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