PYXIS 3D Titanium Cervical Cage System 8072-0806S

GUDID 08809885704155

"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The implants are made of polyether-ether-ketone (PEEK OPTIMA LT1) (Manufacturer – INVIBIO) body (PEEK conforming to ASTM F2026) with the x-ray markers made of Tantulum (conforming to ASTM F560). The AnyPlus PEEK Lumbar Cage is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (""DDD"") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The AnyPlus PEEK Lumbar Cage is to be combined with internal supplemental fixation cleared for use in the lumbar spine."

GS Medical Co., Ltd.

Polymeric spinal interbody fusion cage
Primary Device ID08809885704155
NIH Device Record Keye65c5619-250c-4901-8a22-8258e46c28db
Commercial Distribution StatusIn Commercial Distribution
Brand NamePYXIS 3D Titanium Cervical Cage System
Version Model Number8072-0806S
Catalog Number8072-0806S
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

Device Identifiers

Device Issuing AgencyDevice ID
GS108809885704155 [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

[08809885704155]

Moist Heat or Steam Sterilization

[08809885704155]

Moist Heat or Steam Sterilization

[08809885704155]

Moist Heat or Steam Sterilization

[08809885704155]

Moist Heat or Steam Sterilization

[08809885704155]

Moist Heat or Steam Sterilization

[08809885704155]

Moist Heat or Steam Sterilization

[08809885704155]

Moist Heat or Steam Sterilization

[08809885704155]

Moist Heat or Steam Sterilization

[08809885704155]

Moist Heat or Steam Sterilization

[08809885704155]

Moist Heat or Steam Sterilization

[08809885704155]

Moist Heat or Steam Sterilization

[08809885704155]

Moist Heat or Steam Sterilization

[08809885704155]

Moist Heat or Steam Sterilization

[08809885704155]

Moist Heat or Steam Sterilization

[08809885704155]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-25
Device Publish Date2025-03-17

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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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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