FDA.reportPublic FDA data

Anyplus Peek Cage System

Primary DI
08806395498604
Brand
Anyplus Peek Cage System
Company
GS Medical Co., Ltd.
Model
1223-0008
Catalog number
1223-0008
Device description
The GS Medical AnyPlus® PEEK Cage System device is designed for restoring the height of the intervertebral space after resection of the disc. AnyPlus® PEEK Cage System device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The intervertebral body fusion devices are made of poly-ether-ether- ketone (PEEK Optima LT1) body with the X-ray (radio-opaque) markers made of Tantalum. The AnyPlus® PEEK Cage System devices are radiolucent allowing X-ray visualization to verify device placement. AnyPlus® PEEK Cage System device is supplied sterile and non-sterile and is intended for single use only. AnyPlus® PEEK Cage System is designed for interbody stabilization of the cervical spine.
Published
2026-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200592000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200592000GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.2020-08-10ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806395498604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806395498604088063954986048806395498604

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+82432377393udimail@gsmedi.com

Regulatory Flags#

DUNS number
688385418
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800322709924VEGA Cervical Screw SystemGTI0108-0003GTI0108-00032026-09-22
08800322709993VEGA Cervical Screw SystemGS128-1600GS128-16002026-09-22
08800322719015VEGA Cervical Screw SystemGS128-0700GS128-07002026-09-22
08800322719022VEGA Cervical Screw SystemGS128-1730GS128-17302026-09-22
08800322759639VEGA Cervical Screw SystemGS128-1010GS128-10102026-09-22
08800322759646VEGA Cervical Screw SystemGS128-1011GS128-10112026-09-22
08800322759653VEGA Cervical Screw SystemGS128-1012GS128-10122026-09-22
08800322759660VEGA Cervical Screw SystemGS128-1013GS128-10132026-09-22
08800322759677VEGA Cervical Screw SystemGS128-1014GS128-10142026-09-22
08800322759684VEGA Cervical Screw SystemGS128-1560GS128-15602026-09-22
08800322759691VEGA Cervical Screw SystemGS128-9000GS128-90002026-09-22
08800322759707VEGA Cervical Screw SystemGS128-9100GS128-91002026-09-22
08800322759714VEGA Cervical Screw SystemGS128-9110GS128-91102026-09-22
08809885759667VEGA Cervical Screw SystemGS128-9011GS128-90112026-09-22
08809885759674VEGA Cervical Screw SystemGS128-9012GS128-90122026-09-22
08809885759797VEGA Cervical Screw SystemGS128-9015GS128-90152026-09-22
08809974779408VEGA Cervical Screw SystemGS128-0200GS128-02002026-09-22
08809974779415VEGA Cervical Screw SystemGS128-0300GS128-03002026-09-22
08809974779422VEGA Cervical Screw SystemGS128-0310GS128-03102026-09-22
08809974779439VEGA Cervical Screw SystemGS128-0320GS128-03202026-09-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840606185127LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185134LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185141LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185158LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185165LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196024VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196031VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196048VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.MAX2026-09-22
10888857461819CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
04546540665720AVS NAVIGATORStryker CorporationMAX2016-09-24
10888857218772CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219489CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219595CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
07613153046196AVS PLStryker CorporationMAX2015-09-14
07613153046202AVS PLStryker CorporationMAX2015-09-14
07613153046219AVS PLStryker CorporationMAX2015-09-14
07613153046226AVS PLStryker CorporationMAX2015-09-14
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07613153046295AVS PLStryker CorporationMAX2015-09-14
07613153046301AVS PLStryker CorporationMAX2015-09-14
07613153046318AVS PLStryker CorporationMAX2015-09-14
07613153046325AVS PLStryker CorporationMAX2015-09-14
07613153046332AVS PLStryker CorporationMAX2015-09-14
07613153046349AVS PLStryker CorporationMAX2015-09-14