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FDA 510(k)

CORNICE Cervical Spacer System

K-Number: K192208 · 2019-10-09

ApplicantLegend Spine Technologies
Decision Date2019-10-09
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CORNICE Cervical Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Legend Spine Technologies. It received FDA 510(k) clearance on 2019-10-09 under 510(k) number K192208. 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 CORNICE Cervical Spacer System?

CORNICE Cervical Spacer System is a medical device that received FDA 510(k) clearance on 2019-10-09. The listed applicant is Legend Spine Technologies. The 510(k) number is K192208.

When did CORNICE Cervical Spacer System receive FDA 510(k) clearance?

CORNICE Cervical Spacer System received FDA 510(k) clearance on 2019-10-09, under 510(k) number K192208.

Who is the listed applicant for CORNICE Cervical Spacer System?

The FDA 510(k) record lists Legend Spine Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORNICE Cervical Spacer System?

The FDA product code for CORNICE Cervical Spacer System is ODP.

Other records listing Legend Spine Technologies 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.

K180071STYLO Interbody Fusion Device

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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