Duns Number:116995646
Device Description: Reduction Cannulated Polyaxial Screw 8.5mm diameter 40mm length for use with a 6.0 Rod
Catalog Number
1118-853-040
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
K101682
Product Code
KWP
Product Code Name
Appliance, Fixation, Spinal Interlaminal
Public Device Record Key
02daa496-89f0-4c15-9e9f-63fa7d819e8c
Public Version Date
July 30, 2019
Public Version Number
5
DI Record Publish Date
October 29, 2015
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 |