PYXIS 3D Titanium X-TLIF Cage, Open 8102-4008S

GUDID 08800322701317

The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral space after resection of the disc.The PYXIS 3D Titanium Cage devices consist of implants in various heights, footprints, and lordotic configurations with architecture designed to accept pre and post packing of bone graft material. The intervertebral body devices are made of titanium alloy (Ti-6AL-4V ELI).The PYXIS 3D Titanium Cage devices are not radio lucent, but have large windows through the sides that will allow visualization of the placement and subsequent bone fusion.

GS Medical Co., Ltd.

Metallic spinal interbody fusion cage
Primary Device ID08800322701317
NIH Device Record Key35140b2b-328b-4b5f-a4b9-7acb71fa65c8
Commercial Distribution StatusIn Commercial Distribution
Brand NamePYXIS 3D Titanium X-TLIF Cage, Open
Version Model Number8102-4008S
Catalog Number8102-4008S
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

Device Identifiers

Device Issuing AgencyDevice ID
GS108800322701317 [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

[08800322701317]

Moist Heat or Steam Sterilization


[08800322701317]

Moist Heat or Steam Sterilization


[08800322701317]

Moist Heat or Steam Sterilization


[08800322701317]

Moist Heat or Steam Sterilization


[08800322701317]

Moist Heat or Steam Sterilization


[08800322701317]

Moist Heat or Steam Sterilization


[08800322701317]

Moist Heat or Steam Sterilization


[08800322701317]

Moist Heat or Steam Sterilization


[08800322701317]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-25
Device Publish Date2025-07-17

On-Brand Devices [PYXIS 3D Titanium X-TLIF Cage, Open]

08809974860274The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809974860267The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809974860250The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809974860229The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809974860212The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809974860205The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885759605The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885759575The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729400The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729394The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729387The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729370The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729363The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729356The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729349The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729332The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729325The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729318The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729301The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729295The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729288The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729271The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729264The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729257The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729240The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729233The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729226The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729219The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729202The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729196The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729189The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729172The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729165The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729158The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729141The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729134The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729127The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729110The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729103The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729097The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729080The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729073The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729066The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729059The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729042The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729035The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729028The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729011The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885729004The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08809885728991The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s

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