NeoFuse Ti3D PLIF/TLIF/Cervical Interbody

Intervertebral Fusion Device With Bone Graft, Cervical

HT Medical, LLC

The following data is part of a premarket notification filed by Ht Medical, Llc with the FDA for Neofuse Ti3d Plif/tlif/cervical Interbody.

Pre-market Notification Details

• Device ID: K170318
• 510k Number: K170318
• Device Name: NeoFuse Ti3D PLIF/TLIF/Cervical Interbody
• Classification: Intervertebral Fusion Device With Bone Graft, Cervical
• Applicant: HT Medical, LLC 6316 E. 102nd Street Tulsa, OK 74137
• Contact: Robert Compton
• Correspondent: Nicholas Cordaro; Additive Innovations, LLC 533 2nd Street, Suite A Encinitas, CA 92024
• Product Code: ODP
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-02-01
• Decision Date: 2017-07-12
• Summary: summary

NIH GUDID Devices

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