PYXIS 3D Titanium Cage System 8001-2815S

GUDID 08800104092077

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 Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage
Primary Device ID08800104092077
NIH Device Record Key157e4051-2255-42e4-bb6b-58e6cecdb05d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePYXIS 3D Titanium Cage System
Version Model Number8001-2815S
Catalog Number8001-2815S
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 Datetrue
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
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
GS108800104092077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[08800104092077]

Radiation Sterilization

[08800104092077]

Radiation Sterilization

[08800104092077]

Radiation Sterilization

[08800104092077]

Radiation Sterilization

[08800104092077]

Radiation Sterilization

[08800104092077]

Radiation Sterilization

[08800104092077]

Radiation Sterilization

[08800104092077]

Radiation Sterilization

[08800104092077]

Radiation Sterilization

[08800104092077]

Radiation Sterilization

[08800104092077]

Radiation Sterilization

[08800104092077]

Radiation Sterilization

[08800104092077]

Radiation Sterilization

[08800104092077]

Radiation Sterilization

[08800104092077]

Radiation Sterilization

[08800104092077]

Radiation Sterilization

[08800104092077]

Radiation Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-23
Device Publish Date2024-04-15

On-Brand Devices [PYXIS 3D Titanium Cage System]

08800104095535The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104096655The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104095313The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104093005The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104092930The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104092893The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
088098857197533D T-PLIF Trial
088098857197463D T-PLIF Trial
088098857197393D T-PLIF Trial
088098857197223D T-PLIF Trial
088098857197153D T-PLIF Trial
088098857197083D T-PLIF Trial
08800104092046The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104092039The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104092022The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104092015The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104092008The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104091995The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104091988The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104091971The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104091964The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104091957The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104091940The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104091933The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104091926The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104091919The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104091902The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104095511The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104092084The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104092077The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104092060The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104092053The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104096792The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104096785The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104096761The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104096747The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
08800104091810The PYXIS 3D Titanium Cage devices are designed for restoring the height of the intervertebral s
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.