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 ID: K201506
• 510k Number: K201506
• Device Name: Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System
• Classification: Intervertebral Fusion Device With Bone Graft, Cervical
• Applicant: Meditech Spine, LLC 1447 Peachtree St NE Suite 440 Atlanta, GA 30309
• Contact: Bruce Dunaway
• Correspondent: Bruce Dunaway; Meditech Spine, LLC 1447 Peachtree St NE Suite 440 Atlanta, GA 30309
• Product Code: ODP
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-06-05
• Decision Date: 2020-09-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B167500061412140	K201506	000
B167500101412140	K201506	000
B167500101614140	K201506	000
B167500101815140	K201506	000
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B167500111815140	K201506	000
B167500121412140	K201506	000
B167500121614140	K201506	000
B167500091815140	K201506	000
B167500091614140	K201506	000
B167500091412140	K201506	000
B167500061614140	K201506	000
B167500061815140	K201506	000
B167500071412140	K201506	000
B167500071614140	K201506	000
B167500071815140	K201506	000
B167500081412140	K201506	000
B167500081614140	K201506	000
B167500081815140	K201506	000
B167500121815140	K201506	000
B167521606140	K201506	000
B167521211140	K201506	000
B167521212140	K201506	000
B167521306140	K201506	000
B167521307140	K201506	000
B167521308140	K201506	000
B167521309140	K201506	000
B167521310140	K201506	000
B167521311140	K201506	000
B167521210140	K201506	000
B167521209140	K201506	000
B167521208140	K201506	000
B167521607140	K201506	000
B167521608140	K201506	000
B167521609140	K201506	000
B167521610140	K201506	000
B167521611140	K201506	000
B167521612140	K201506	000
B167521206140	K201506	000
B167521207140	K201506	000
B167521312140	K201506	000