Duns Number:183641617
Device Description: INTERSPINOUS PUNCH, 4MM
Catalog Number
132-1-033
Brand Name
Aileron Posterior Fusion System
Version/Model Number
132-1-033
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
-
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
K100407
Product Code
PEK
Product Code Name
Spinous process plate
Public Device Record Key
451223f6-90d9-40d1-aca7-4d38841516d4
Public Version Date
November 12, 2019
Public Version Number
1
DI Record Publish Date
November 04, 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 | 315 |
2 | A medical device with a moderate to high risk that requires special controls. | 9180 |
U | Unclassified | 47 |