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FDA 510(k)

CYGNUS-C Standalone ACIF System

K-Number: K222041 · 2023-02-09

ApplicantGS Medical Co., Ltd.
Decision Date2023-02-09
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CYGNUS-C Standalone ACIF System is the device name listed in this FDA 510(k) record. The listed applicant is GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-02-09 under 510(k) number K222041. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYGNUS-C Standalone ACIF System?

CYGNUS-C Standalone ACIF System is a medical device that received FDA 510(k) clearance on 2023-02-09. The listed applicant is GS Medical Co., Ltd.. The 510(k) number is K222041.

When did CYGNUS-C Standalone ACIF System receive FDA 510(k) clearance?

CYGNUS-C Standalone ACIF System received FDA 510(k) clearance on 2023-02-09, under 510(k) number K222041.

Who is the listed applicant for CYGNUS-C Standalone ACIF System?

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

What is the FDA product code for CYGNUS-C Standalone ACIF System?

The FDA product code for CYGNUS-C Standalone ACIF System is OVE.

Other records listing GS Medical 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.

K243073AnyPlus Navigated Instruments SystemK241738PYXIS 3D Titanium Cervical Cage systemK240350AnyPlus II Spinal Fixation SystemK231808QUASAR Standalone ACIF SystemK223868PYXIS 3D Titanium Cage SystemK221687Pegasus-X Expandable PLIF System

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Related Devices (Code: OVE)

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.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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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