Duns Number:042418840
Device Description: Libra Rod, Straight, 400mm
Catalog Number
-
Brand Name
Libra Pedicle Screw System
Version/Model Number
LROD400
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
K151770
Product Code
MNH
Product Code Name
Orthosis, Spondylolisthesis Spinal Fixation
Public Device Record Key
d18219eb-755d-4cdb-b927-f6bec33c0291
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 10, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 91 |