AnyPlus PEEK Lumbar Fusion Cages 1189-1265

GUDID 08806395422104

"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 ID08806395422104
NIH Device Record Key8adfd6ee-dd88-45d1-8ac5-5f9a142e9150
Commercial Distribution Discontinuation2016-04-28
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAnyPlus PEEK Lumbar Fusion Cages
Version Model Number1189-1265
Catalog Number1189-1265
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 Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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
Phone+82432377393
Emailudimail@gsmedi.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108806395422104 [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

[08806395422104]

Moist Heat or Steam Sterilization

[08806395422104]

Moist Heat or Steam Sterilization

[08806395422104]

Moist Heat or Steam Sterilization

[08806395422104]

Moist Heat or Steam Sterilization

[08806395422104]

Moist Heat or Steam Sterilization

[08806395422104]

Moist Heat or Steam Sterilization

[08806395422104]

Moist Heat or Steam Sterilization

[08806395422104]

Moist Heat or Steam Sterilization

[08806395422104]

Moist Heat or Steam Sterilization

[08806395422104]

Moist Heat or Steam Sterilization

[08806395422104]

Moist Heat or Steam Sterilization

[08806395422104]

Moist Heat or Steam Sterilization

[08806395422104]

Moist Heat or Steam Sterilization

[08806395422104]

Moist Heat or Steam Sterilization

[08806395422104]

Moist Heat or Steam Sterilization

[08806395422104]

Moist Heat or Steam Sterilization

[08806395422104]

Moist Heat or Steam Sterilization

[08806395422104]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2016-04-28

On-Brand Devices [AnyPlus PEEK Lumbar Fusion Cages]

08806395422111"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395422104"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395422098"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395422081"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395422074"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395422067"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395422050"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395422043"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395422036"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395422029"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395422012"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395422005"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421992"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421985"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421978"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421961"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421954"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421947"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421930"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421923"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421916"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421909"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421893"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421886"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421879"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421862"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421855"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421848"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421831"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421824"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421817"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421800"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421794"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421787"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421770"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421763"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421756"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421749"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421732"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421725"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421718"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421701"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421695"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421688"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421671"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421664"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421657"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421640"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421633"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
08806395421626"The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.