Duns Number:649220779
Device Description: Straight Rod Ø6.0x250mm Hex Edge
Catalog Number
-
Brand Name
ProMIS™ Fixation System
Version/Model Number
87343
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
K150380
Product Code
MNH
Product Code Name
Orthosis, Spondylolisthesis Spinal Fixation
Public Device Record Key
7a05ab0c-02e2-4f79-8d5b-4aa15586e39b
Public Version Date
July 11, 2018
Public Version Number
1
DI Record Publish Date
June 10, 2018
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 40 |