PYXIS 3D Titanium Cervical Cage, Close 8070-1213S

GUDID 08800322751589

The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the height of the intervertebral space after resection of the disc. The intervertebral body fusion devices are made of 3D printed titanium alloy (Ti-6Al-4V) in accordance with and manufactured as per ASTM F3001. The material and manufacturing process of the subject device, PYXIS 3D Titanium Cervical Cage is identical to the additional predicate (PYXIS 3D Titanium Cage System, K223868). The PYXIS 3D Titanium Cervical Cage System implants are available in various heights, footprints, and lordotic angles to suit the individual patient’s pathology and anatomical conditions. The subject device cages ranging in height from 5mm-10mm in 1 mm increments with 0°, 4°, and 8° options. Also in 4.5mm hight for the 0° angle. The cages are provided in three distinct footprints.

GS Medical Co., Ltd.

Metallic spinal interbody fusion cage
Primary Device ID08800322751589
NIH Device Record Keyfd20333c-150e-41d3-aa6f-4f05bfe4889f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePYXIS 3D Titanium Cervical Cage, Close
Version Model Number8070-1213S
Catalog Number8070-1213S
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
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108800322751589 [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

[08800322751589]

Moist Heat or Steam Sterilization

[08800322751589]

Moist Heat or Steam Sterilization

[08800322751589]

Moist Heat or Steam Sterilization

[08800322751589]

Moist Heat or Steam Sterilization

[08800322751589]

Moist Heat or Steam Sterilization

[08800322751589]

Moist Heat or Steam Sterilization

[08800322751589]

Moist Heat or Steam Sterilization

[08800322751589]

Moist Heat or Steam Sterilization

[08800322751589]

Moist Heat or Steam Sterilization

[08800322751589]

Moist Heat or Steam Sterilization

[08800322751589]

Moist Heat or Steam Sterilization

[08800322751589]

Moist Heat or Steam Sterilization

[08800322751589]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-05
Device Publish Date2026-01-28

On-Brand Devices [ PYXIS 3D Titanium Cervical Cage, Close]

088098857397513D Cervical Cage Impactor
08809695601859Wide Nerve Root Retractor, Long 90
08809695589973Poly Screw Driver
08806162109436Pin Driver
08806162109399Cage Holder
08806162109382Cage Holder
08806162109351Bone Impactor
08800322752098Tamp
08800322752081SA ACIF Cage Caddy
08800322752074SA ACIF Cage Caddy
08800322752067SA ACIF Cage Caddy
08800322752050SA ACIF Cage Caddy
08800322752043Rasp Lolly Pop Type
08800322752036The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322752029The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322752012The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322752005The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751992The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751985The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751978The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751961The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751954The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751947The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751930The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751923The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751916The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751909The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751893The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751886The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751879The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751862The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751855The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751848The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751831The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751824The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751817The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751800The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751794The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751787The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751770The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751763The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751756The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751749The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751732The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751725The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751718The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751701The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751695The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751688The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
08800322751671The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the hei
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.