Duns Number:078331322
Device Description: 22 x 10 x 18 mm, PEEK Silverstone-P
Catalog Number
-
Brand Name
Silverstone Interbody Fusion System
Version/Model Number
SP221018
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
-
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
-
Product Code
MQP
Product Code Name
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Public Device Record Key
3b16bf26-2e47-46e7-9bc4-3eb298ce6777
Public Version Date
February 24, 2020
Public Version Number
3
DI Record Publish Date
October 28, 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1308 |