Duns Number:079398589
Device Description: Slimplicity Plus ACP - 4 level, 81mm
Catalog Number
ACP481P
Brand Name
Slimplicity Plus Anterior Cervical Plating System
Version/Model Number
ACP481P
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
K060025
Product Code
KWQ
Product Code Name
Appliance, Fixation, Spinal Intervertebral Body
Public Device Record Key
e00b43c7-e69f-4a98-8f07-10096741d596
Public Version Date
April 04, 2019
Public Version Number
1
DI Record Publish Date
March 27, 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 | 1423 |
2 | A medical device with a moderate to high risk that requires special controls. | 4960 |
U | Unclassified | 26 |