Duns Number:079398589
Device Description: 4.5 x 12mm Variable Screw
Catalog Number
08-4512v
Brand Name
Slimplicity Anterior Cervical Plate System
Version/Model Number
08-4512v
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
K112748
Product Code
KWQ
Product Code Name
Appliance, Fixation, Spinal Intervertebral Body
Public Device Record Key
1aeadd02-0217-4670-b469-76aa2a210a19
Public Version Date
October 21, 2020
Public Version Number
3
DI Record Publish Date
March 29, 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 |