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.
Catalog Number
1182-5411
Brand Name
AnyPlus Cervical PEEK Cage System
Version/Model Number
1182-5411
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 30, 2016
Issuing Agency
In GS1
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
ODP
Product Code Name
Intervertebral Fusion Device With Bone Graft, Cervical
Public Device Record Key
04a5de12-6f52-495e-bbdd-608c6c0ee84a
Public Version Date
February 24, 2020
Public Version Number
4
DI Record Publish Date
August 30, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |