Duns Number:688385418
Device Description: "The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixati "The GSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, locking spacer, and a transverse (cross) linking mechanism. The GSS Pedicle Screw System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The GSS Pedicle Screw System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the GSS Pedicle Screw System. The GSS Pedicle Screw System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-SI vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion."
Catalog Number
GS0122-5535
Brand Name
GSS Pedicle Screw System
Version/Model Number
GS0122-5535
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 22, 2016
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"
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
K053573
Product Code
MNH
Product Code Name
Orthosis, Spondylolisthesis Spinal Fixation
Public Device Record Key
1c271b8f-49aa-495b-a28f-2979d6e1db14
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 22, 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 | 280 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7396 |