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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 the device name listed in this FDA 510(k) record. The listed applicant is Hd Lifesciences, LLC. It received FDA 510(k) clearance on 2018-06-27 under 510(k) 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. The listed applicant is Hd Lifesciences, LLC. The 510(k) number is K180364.

When did HD LifeSciences Cervical IBFD System receive FDA 510(k) clearance?

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

Who is the listed applicant for HD LifeSciences Cervical IBFD System?

The FDA 510(k) record lists Hd Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Hd Lifesciences, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemK170676HD Lumbar Interbody System

Related Devices (Code: ODP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.

Official Source

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

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