QUASAR Standalone ACIF System 8361-1205S

GUDID 08809974809341

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).

GS Medical Co., Ltd.

Metallic spinal interbody fusion cage
Primary Device ID08809974809341
NIH Device Record Keyf03ffb3b-5885-404f-9610-47b2d174b8f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameQUASAR Standalone ACIF System
Version Model Number8361-1205S
Catalog Number8361-1205S
Company DUNS688385418
Company NameGS Medical Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108809974809341 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809974809341]

Moist Heat or Steam Sterilization

[08809974809341]

Moist Heat or Steam Sterilization

[08809974809341]

Moist Heat or Steam Sterilization

[08809974809341]

Moist Heat or Steam Sterilization

[08809974809341]

Moist Heat or Steam Sterilization

[08809974809341]

Moist Heat or Steam Sterilization

[08809974809341]

Moist Heat or Steam Sterilization

[08809974809341]

Moist Heat or Steam Sterilization

[08809974809341]

Moist Heat or Steam Sterilization

[08809974809341]

Moist Heat or Steam Sterilization

[08809974809341]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-09
Device Publish Date2025-09-01

On-Brand Devices [QUASAR Standalone ACIF System]

08809885799892Quasar Trial Without Stopper
08809885799885Quasar Trial Without Stopper
08809885799878Quasar Trial Without Stopper
08809885799861Quasar Trial Without Stopper
08809885799854Quasar Trial Without Stopper
08809885799847Quasar Trial Without Stopper
08809885799830Quasar Trial Without Stopper
08809885799823Quasar Trial Without Stopper
08809885799809Angled Drill Tip with Sleeve
08809974816127Quick Lock
08809974799840SA ACIF Cage Caddy
08809974799833SA ACIF Cage Caddy
08800322709573TRIAL, UNIVERSAL
08800322709566TRIAL, UNIVERSAL
08800322709559TRIAL, UNIVERSAL
08800322709542TRIAL, UNIVERSAL
08800322709535TRIAL, UNIVERSAL
08800322709528TRIAL, UNIVERSAL
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08800322709504TRIAL, UNIVERSAL
08800322709498TRIAL, UNIVERSAL
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08800322709474TRIAL, UNIVERSAL
08800322709467TRIAL, UNIVERSAL
08800322709450TRIAL, UNIVERSAL
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08800322709399TRIAL, UNIVERSAL
08800322709382TRIAL, UNIVERSAL
08800322709375TRIAL, UNIVERSAL
08800322709368TRIAL, UNIVERSAL
08800322709351TRIAL, UNIVERSAL
08800322709344TRIAL, UNIVERSAL
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08800322709320TRIAL, UNIVERSAL
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08800322709290TRIAL, UNIVERSAL
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08800322709245TRIAL, UNIVERSAL
08800322709238TRIAL, UNIVERSAL
08800322709221TRIAL, UNIVERSAL
08800322709214SA ACIF Holder
08809974809389The subject device, the QUASAR Standalone ACIF System cages are designed for restoring the heigh
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