FDA.reportPublic FDA data

QUASAR Standalone ACIF System

Primary DI
08809974865637
Brand
QUASAR Standalone ACIF System
Company
GS Medical Co., Ltd.
Model
6040-4009S
Catalog number
6040-4009S
Device description
The subject device, the QUASAR 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 the user to bypass using an additional plate as seen with traditional ACIF spacers. The QUASAR 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 supplementary fixation screws are used along with the subject device cage and plate.The intervertebral body fusion devices are made of hydroxyapatite polyether-ether-ketone (HA PEEK OPTIMA LT1) body with Titanium alloy plates (Ti-6Al-4V) and supplementary screws made up of Titanium alloy (Ti-6Al-4V).
Published
2026-04-23
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
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231808000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231808000QUASAR Standalone ACIF SystemGS Medical Co., Ltd.2023-07-20OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809974865637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809974865637088099748656378809974865637

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
08800322775561Sheathe BladeGS152-1001GS152-10012026-09-18
08800322775578Sheathe BladeGS152-1002GS152-10022026-09-18
08800322775585Sheathe BladeGS152-1003GS152-10032026-09-18
08800322775592Sheathe BladeGS152-1004GS152-10042026-09-18
08800322775608Sheathe BladeGS152-1005GS152-10052026-09-18
08800322775615Sheathe BladeGS152-1006GS152-10062026-09-18
08800322775622Sheathe BladeGS152-1007GS152-10072026-09-18
08800322775639Sheathe BladeGS152-1008GS152-10082026-09-18
08800322775646Sheathe BladeGS152-1101GS152-11012026-09-18
08800322775653Sheathe BladeGS152-1102GS152-11022026-09-18
08800322775660Sheathe BladeGS152-1103GS152-11032026-09-18
08800322775677Sheathe BladeGS152-1104GS152-11042026-09-18
08800322775684Sheathe BladeGS152-1105GS152-11052026-09-18
08800322775691Sheathe BladeGS152-1106GS152-11062026-09-18
08800322775707Sheathe BladeGS152-1107GS152-11072026-09-18
08800322775714Sheathe BladeGS152-1108GS152-11082026-09-18
08800322776391QUASAR Standalone ACIF System6008-00056008-00052026-09-18
08800322776407QUASAR Standalone ACIF System6008-00066008-00062026-09-18
08800322776414QUASAR Standalone ACIF System6008-00076008-00072026-09-18
08800322776421QUASAR Standalone ACIF System6008-00086008-00082026-09-18

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