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FDA 510(k)

C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE

K-Number: K121320 · 2012-08-10

ApplicantMedyssey Co, Ltd.
Decision Date2012-08-10
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE is the device name listed in this FDA 510(k) record. The listed applicant is Medyssey Co, Ltd.. It received FDA 510(k) clearance on 2012-08-10 under 510(k) number K121320. 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 C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE?

C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE is a medical device that received FDA 510(k) clearance on 2012-08-10. The listed applicant is Medyssey Co, Ltd.. The 510(k) number is K121320.

When did C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE receive FDA 510(k) clearance?

C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE received FDA 510(k) clearance on 2012-08-10, under 510(k) number K121320.

Who is the listed applicant for C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE?

The FDA 510(k) record lists Medyssey Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE?

The FDA product code for C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE is ODP.

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Other records listing Medyssey Co, Ltd. 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.

K260036NeckTune™ 3D SA Cervical CageK242806Medyssey Navigation SystemK121670MEDYSSEY CANNULATED PEDICLE SCREWK121246MEDYSSY LT CAGE SYSTEMK110284NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEMK110283ZENIUS SPINAL SYSTEM

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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.

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.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.

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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