Duns Number:116995646
Device Description: ACP, Ø4.5mm x 11mm, Revision Fixed Angle Screw, Self-Tapping
Catalog Number
1140-445-011
Brand Name
Kyocera Medical Technologies, Inc.
Version/Model Number
S 140
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
K152193
Product Code
KWQ
Product Code Name
Appliance, Fixation, Spinal Intervertebral Body
Public Device Record Key
9326c4f0-0de7-45a0-806d-160077810d1c
Public Version Date
July 18, 2019
Public Version Number
6
DI Record Publish Date
November 21, 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 | 2246 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3237 |