Duns Number:342243334
Device Description: Polyaxial screw,w/o cannulation 7.5/60mm
Catalog Number
PSS11-17560
Brand Name
Polyaxial screw,w/o cannulation 7.5/60mm
Version/Model Number
PSS11-17560
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
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
Orthosis, spinal pedicle fixation, for degenerative disc disease
Public Device Record Key
da54fbd1-3800-48af-9667-981a93f8b819
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 07, 2016
Package DI Number
EMAHPSS11175601
Quantity per Package
1
Contains DI Package
EMAHPSS11175600
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 19 |
2 | A medical device with a moderate to high risk that requires special controls. | 1976 |