Duns Number:078812602
Device Description: Rod, Straight, MIS, 5.5 X 180, CoCr
Catalog Number
0122-55180
Brand Name
F1 MPS Modular Pedicle Screw System
Version/Model Number
0122-55180
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
-
Product Code
MNH
Product Code Name
Orthosis, spondylolisthesis spinal fixation
Public Device Record Key
259e7691-76b5-4fb1-8d64-a2277ecb2f91
Public Version Date
May 24, 2018
Public Version Number
1
DI Record Publish Date
April 23, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 511 |
2 | A medical device with a moderate to high risk that requires special controls. | 4143 |