Duns Number:116995646
Device Description: Cannulated Polyaxial Screw 8.5mm diameter 85mm length for use with a 5.5 Rod
Catalog Number
1115-853-085
Brand Name
Kyocera Medical Technologies, Inc.
Version/Model Number
S 100
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
K111940
Product Code
MNH
Product Code Name
Orthosis, Spondylolisthesis Spinal Fixation
Public Device Record Key
1d82606c-0435-400c-bf5c-fc4bb4df9c90
Public Version Date
July 18, 2019
Public Version Number
3
DI Record Publish Date
January 16, 2019
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 | 2246 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3237 |