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FDA 510(k)

NeoFuse Ti3D PLIF/TLIF/Cervical Interbody

K-Number: K170318 · 2017-07-12

ApplicantHt Medical, LLC
Decision Date2017-07-12
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NeoFuse Ti3D PLIF/TLIF/Cervical Interbody is a medical device manufactured by Ht Medical, LLC. It received FDA 510(k) clearance on 2017-07-12 under approval number K170318. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeoFuse Ti3D PLIF/TLIF/Cervical Interbody?

NeoFuse Ti3D PLIF/TLIF/Cervical Interbody is a medical device that received FDA 510(k) clearance on 2017-07-12. It is manufactured by Ht Medical, LLC. The 510(k) number is K170318.

When was NeoFuse Ti3D PLIF/TLIF/Cervical Interbody approved by the FDA?

NeoFuse Ti3D PLIF/TLIF/Cervical Interbody received FDA 510(k) clearance on 2017-07-12, under approval number K170318.

What company makes NeoFuse Ti3D PLIF/TLIF/Cervical Interbody?

NeoFuse Ti3D PLIF/TLIF/Cervical Interbody is manufactured by Ht Medical, LLC.

What is the FDA product code for NeoFuse Ti3D PLIF/TLIF/Cervical Interbody?

The FDA product code for NeoFuse Ti3D PLIF/TLIF/Cervical Interbody is ODP.

Related Clinical Trials

NCT04214535 Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels ACTIVE_NOT_RECRUITING

Other Devices by Ht Medical, LLC

K153615NeoFuse HA Enhanced PLIF/TLIF K170511NeoFuse HA Enhanced PLIF/TLIF

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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