PYXIS 3D Titanium Cervical Cage System 8061-0406S

GUDID 08809885703424

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.

Polymeric spinal interbody fusion cage
Primary Device ID08809885703424
NIH Device Record Key319fb8ca-1724-4ece-b980-9bfd615bb30d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePYXIS 3D Titanium Cervical Cage System
Version Model Number8061-0406S
Catalog Number8061-0406S
Company DUNS688385418
Company NameGS Medical Co., Ltd.
Device Count1
DM Exempttrue
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
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
GS108809885703424 [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

[08809885703424]

Moist Heat or Steam Sterilization

[08809885703424]

Moist Heat or Steam Sterilization

[08809885703424]

Moist Heat or Steam Sterilization

[08809885703424]

Moist Heat or Steam Sterilization

[08809885703424]

Moist Heat or Steam Sterilization

[08809885703424]

Moist Heat or Steam Sterilization

[08809885703424]

Moist Heat or Steam Sterilization

[08809885703424]

Moist Heat or Steam Sterilization

[08809885703424]

Moist Heat or Steam Sterilization

[08809885703424]

Moist Heat or Steam Sterilization

[08809885703424]

Moist Heat or Steam Sterilization

[08809885703424]

Moist Heat or Steam Sterilization

[08809885703424]

Moist Heat or Steam Sterilization

[08809885703424]

Moist Heat or Steam Sterilization

[08809885703424]

Moist Heat or Steam Sterilization

[08809885703424]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-22
Device Publish Date2025-04-14

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

08809974799581"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809974799390"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809974799208"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885704193"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885704186"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885704179"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885704162"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885704155"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885704148"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885704131"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885704124"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885704117"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885704100"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885704094"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885704087"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885704070"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885704063"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885704056"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885704049"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885704032"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885704025"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
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08809885704001"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703998"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703981"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703974"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703967"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703950"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703943"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703936"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703929"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703912"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703905"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703899"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703882"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703875"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703868"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703851"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703844"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703837"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703820"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703813"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703806"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703790"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703783"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703776"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703769"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703752"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703745"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08809885703738"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
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