Duns Number:688385418
Device Description: The AnyPlus Spinal Fixation System consists of various hooks, screws, rods and connectors
Catalog Number
GS0162-0125-M0
Brand Name
AnyPlus Spinal Fixation System
Version/Model Number
GS0162-0125-M0
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 22, 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
K091717
Product Code
KWP
Product Code Name
Appliance, Fixation, Spinal Interlaminal
Public Device Record Key
a63a7b98-cbf1-45e7-9d1d-e7f75ea29832
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 22, 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 |