AnyPlus PEEK Lumbar Fusion Cage

Primary DI
08806395420063
Brand
AnyPlus PEEK Lumbar Fusion Cage
Company
GS Medical Co., Ltd.
Model
1141-1412
Catalog number
1141-1412
Device description
"""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."""
Published
2016-04-26
Public version status
Update
Distribution status
Not 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
K131612000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131612000ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGESGS Medical Co., Ltd.2014-04-18MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806395420063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806395420063088063954200638806395420063

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
DM exempt
true
Lot or batch
true
Serial number
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809695601903AnyPlus®GS138-5800GS138-58002026-04-21
08809974806043PYXIS 3D Titanium Cage SystemGS132-3210PGS132-3210P2025-10-14
08809974806050PYXIS 3D Titanium Cage SystemGS132-3212PGS132-3212P2025-10-14
08809974806074PYXIS 3D Titanium Cage SystemGS132-3214PGS132-3214P2025-10-14
08809974806128PYXIS 3D Titanium Cage SystemGS132-3610PGS132-3610P2025-10-14
08809974806135PYXIS 3D Titanium Cage SystemGS132-3612PGS132-3612P2025-10-14
08809974806159PYXIS 3D Titanium Cage SystemGS132-3614PGS132-3614P2025-10-14
08809974806890PYXIS 3D Titanium Cage SystemGS132-6610PGS132-6610P2025-10-14
08809974806906PYXIS 3D Titanium Cage SystemGS132-6612PGS132-6612P2025-10-14
08809974806920PYXIS 3D Titanium Cage SystemGS132-6614PGS132-6614P2025-10-14
08800322752043AnyPlus®GS136-3500GS136-35002026-01-28
08800322752067QUASAR Standalone ACIF SystemGS136-9661GS136-96612026-01-28
08800322752074QUASAR Standalone ACIF SystemGS136-9662GS136-96622026-01-28
08800322752081QUASAR Standalone ACIF SystemGS136-9668GS136-96682026-01-28
08800322752098AnyPlus®GS136-3311GS136-33112026-01-28
08806162109351AnyPlus®GS136-1410GS136-14102026-01-28
08806162109382AnyPlus®GS136-1800GS136-18002026-01-28
08806162109399AnyPlus®GS136-1801GS136-18012026-01-28
08809695589973PYXIS 3D Titanium Cervical Cage, CloseGS110-0981GS110-09812026-01-28
08809695601859AnyPlus®GS138-5520GS138-55202026-01-28

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