AnyPlus Cervical PEEK Cage System - The GS Medical AnyPlus® Cervical PEEK Cage device - GS Medical Co., Ltd.

Duns Number:688385418

Device Description: The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the intervertebral space after resection of the disc. AnyPlus® Cervical PEEK Cage 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® Cervical PEEK Cage devices are radiolucent allowing X-ray visualization to verify device placement.AnyPlus® Cervical PEEK Cage device is supplied non-sterile and is intended for single use only.AnyPlus® Cervical PEEK Cage is designed for interbody stabilization of the cervical spine.

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More Product Details

Catalog Number

1182-5407

Brand Name

AnyPlus Cervical PEEK Cage System

Version/Model Number

1182-5407

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K153517

Product Code Details

Product Code

ODP

Product Code Name

Intervertebral Fusion Device With Bone Graft, Cervical

Device Record Status

Public Device Record Key

6055a712-b145-4947-83c2-6262e2ba0ef9

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

August 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GS MEDICAL CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 280
2 A medical device with a moderate to high risk that requires special controls. 7396