FDA.reportPublic FDA data

QUASAR Standalone ACIF System

Primary DI
08800322759547
Brand
QUASAR Standalone ACIF System
Company
GS Medical Co., Ltd.
Model
GS136-8209
Catalog number
GS136-8209
Device description
SA ACIF Trial without Stopper
Published
2026-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800322759547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800322759547088003227595478800322759547

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable 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
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800104097980Anyplus II Spinal Fixation SystemGS120-1700GS120-17002026-08-18
08800322750834PYXIS 3D Titanium Cage SystemGS138-5814GS138-58142026-08-18
08800322758106PYXIS 3D Titanium Cage SystemGS138-5815GS138-58152026-08-18
08800322758113PYXIS 3D Titanium Cage SystemGS138-5816GS138-58162026-08-18
08800322759516Torque Limiting HandleGS112-0611GS112-06112026-08-18
08800322759523QUASAR Standalone ACIF SystemGS136-8205GS136-82052026-08-18
08800322759530QUASAR Standalone ACIF SystemGS136-8207GS136-82072026-08-18
08800322759554QUASAR Standalone ACIF SystemGS136-8211GS136-82112026-08-18
08800322759561QUASAR Standalone ACIF SystemGS136-8405GS136-84052026-08-18
08800322759578QUASAR Standalone ACIF SystemGS136-8407GS136-84072026-08-18
08800322759585QUASAR Standalone ACIF SystemGS136-8409GS136-84092026-08-18
08800322759592QUASAR Standalone ACIF SystemGS136-8411GS136-84112026-08-18
08806395408481DistractorGS133-1157GS133-11572026-08-18
08809974805459PYXIS 3D Titanium Cage SystemGS132-1008PGS132-1008P2026-08-18
08809974805466PYXIS 3D Titanium Cage SystemGS132-1009PGS132-1009P2026-08-18
08809974805473PYXIS 3D Titanium Cage SystemGS132-1010PGS132-1010P2026-08-18
08809974805480PYXIS 3D Titanium Cage SystemGS132-1012PGS132-1012P2026-08-18
08809974805497PYXIS 3D Titanium Cage SystemGS132-1014PGS132-1014P2026-08-18
08809974805503PYXIS 3D Titanium Cage SystemGS132-1016PGS132-1016P2026-08-18
08809974805510PYXIS 3D Titanium Cage SystemGS132-1018PGS132-1018P2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M9432002220000MinutemanSpinal Simplicity, LLCLXH2026-09-04
07613327697209PANGEAStryker GmbHLXH2026-08-27
00840606185950ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185967ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185974ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185981ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185998ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186001ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186018ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186025ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186032ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186049ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186056ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186063ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186070ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186087ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186094ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186100ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186117ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186124ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186131ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186148ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186155ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186162ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186179ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186186ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186193ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186209ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186247ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186254ALIFSPINAL ELEMENTS, INC.LXH2026-08-26