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FDA 510(k)

HD LifeSciences Cervical IBFD System

K-Number: K180364 · 2018-06-27

ApplicantHd Lifesciences, LLC
Decision Date2018-06-27
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HD LifeSciences Cervical IBFD System is a medical device manufactured by Hd Lifesciences, LLC. It received FDA 510(k) clearance on 2018-06-27 under approval number K180364. 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 HD LifeSciences Cervical IBFD System?

HD LifeSciences Cervical IBFD System is a medical device that received FDA 510(k) clearance on 2018-06-27. It is manufactured by Hd Lifesciences, LLC. The 510(k) number is K180364.

When was HD LifeSciences Cervical IBFD System approved by the FDA?

HD LifeSciences Cervical IBFD System received FDA 510(k) clearance on 2018-06-27, under approval number K180364.

What company makes HD LifeSciences Cervical IBFD System?

HD LifeSciences Cervical IBFD System is manufactured by Hd Lifesciences, LLC.

What is the FDA product code for HD LifeSciences Cervical IBFD System?

The FDA product code for HD LifeSciences Cervical IBFD System is ODP.

Related Clinical Trials

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Other Devices by Hd Lifesciences, LLC

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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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