Duns Number:606417780
Device Description: PrimaLIF LLIF 15mm x 26mm Parallel Trial
Catalog Number
814-1015
Brand Name
OsteoMed
Version/Model Number
814-1015
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 29, 2017
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
-
Product Code
MAX
Product Code Name
Intervertebral fusion device with bone graft, lumbar
Public Device Record Key
2583ac03-735a-4735-976e-890c0a50b03d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 25, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 95 |
2 | A medical device with a moderate to high risk that requires special controls. | 7762 |
U | Unclassified | 105 |