FDA.reportPublic FDA data

GluOn-IF Stand-alone ACIF Cage System

Primary DI
08809885711597
Brand
GluOn-IF Stand-alone ACIF Cage System
Company
GS Medical Co., Ltd.
Model
6091-1018
Catalog number
6091-1018
Device description
The CYGNUS-C Standalone ACIF System cages are designed for restoring the height of the intervertebral space after resection of the disc while also providing biomechanical stability with the addition on an integrated plate. This integrated plate allows for theuser to bypass using an additional plate as seen with traditional ACIF spacers. The CYGNUS-C Standalone ACIF System devices consist of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The Subject device also contains supplementary fixation screw. The intervertebral body fusion devices are made of hydroxyapatite polyether-ether-ketone (HA PEEK OPTIMA LT1) body with a titanium alloy (Ti-6Al-4V) plate and X-ray (radioopaque) markers made of tantalum. The supplementary screws are made up of titanium alloy (Ti-6Al-4V).
Published
2023-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222041000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222041000CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.2023-02-09OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809885711597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809885711597088098857115978809885711597

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+82432377393udimail@gsmedi.com

Regulatory Flags#

DUNS number
688385418
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800322740446Anyplus II Spinal Fixation System3885-75403885-75402025-12-23
08800322740453Anyplus II Spinal Fixation System3885-75453885-75452025-12-23
08800322740460Anyplus II Spinal Fixation System3885-75503885-75502025-12-23
08800322740477Anyplus II Spinal Fixation System3885-75553885-75552025-12-23
08800322740484Anyplus II Spinal Fixation System3885-75603885-75602025-12-23
08800322740491Anyplus II Spinal Fixation System3885-75653885-75652025-12-23
08800322740507Anyplus II Spinal Fixation System3885-75703885-75702025-12-23
08800322740514Anyplus II Spinal Fixation System3885-75753885-75752025-12-23
08800322740521Anyplus II Spinal Fixation System3885-75803885-75802025-12-23
08800322740538Anyplus II Spinal Fixation System3885-75853885-75852025-12-23
08800322740545Anyplus II Spinal Fixation System3885-75903885-75902025-12-23
08800322740552Anyplus II Spinal Fixation System3885-75953885-75952025-12-23
08800322740569Anyplus II Spinal Fixation System3885-75003885-75002025-12-23
08800322740576Anyplus II Spinal Fixation System3885-80303885-80302025-12-23
08800322740583Anyplus II Spinal Fixation System3885-80353885-80352025-12-23
08800322740590Anyplus II Spinal Fixation System3885-80403885-80402025-12-23
08800322740606Anyplus II Spinal Fixation System3885-80453885-80452025-12-23
08800322740613Anyplus II Spinal Fixation System3885-80503885-80502025-12-23
08800322740620Anyplus II Spinal Fixation System3885-80553885-80552025-12-23
08800322740637Anyplus II Spinal Fixation System3885-80603885-80602025-12-23

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Primary DI, Brand, Company table
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