AnyPlus PEEK Lumbar Fusion Cage 1109-0709

GUDID 08806162121544

"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 ID: 08806162121544
• NIH Device Record Key: 1980404c-3229-4f36-8507-c7728fa0c792
• Commercial Distribution Discontinuation: 2016-04-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AnyPlus PEEK Lumbar Fusion Cage
• Version Model Number: 1109-0709
• Catalog Number: 1109-0709
• Company DUNS: 688385418
• Company Name: GS Medical Co., Ltd.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +82432377393
• Email: udimail@gsmedi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806162121544 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131612

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08806162121544]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-04-26

On-Brand Devices [AnyPlus PEEK Lumbar Fusion Cage]

• 08806162121209: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395420315: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395420308: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
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• 08806395420261: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395420254: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395420247: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395420230: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395420223: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
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• 08806395420186: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395420179: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395420162: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395420155: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395420148: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395420131: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395420124: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395420117: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395420100: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395420094: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395420087: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395420070: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395420063: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395420056: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395420049: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395420032: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395420025: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395420018: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395420001: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395419999: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395419982: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395419975: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395419968: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
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• 08806395419944: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395419937: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395419920: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395419913: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395419906: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395419890: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
• 08806395419883: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height
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• 08806395419838: "The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various height