Duns Number:480789465
Device Description: icotec Pedicle System 6.0, Screw, Ti, Polyax., Fen., Ø 8.5 x 45 mm
Catalog Number
-
Brand Name
icotec Pedicle System 6.0, Screw, Ti, Polyax., Fen., Ø 8.5 x 45 mm
Version/Model Number
16-6022-98545
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
NKB
Product Code Name
Thoracolumbosacral Pedicle Screw System
Public Device Record Key
4c85d5a8-5ff4-45b1-bf10-9406d6eaf2ab
Public Version Date
November 04, 2020
Public Version Number
1
DI Record Publish Date
October 27, 2020
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. | 651 |