Duns Number:656680902
Device Description: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments thatallow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom SpinalFixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants aremade of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided nonsterile,and the implants are for single use only.
Catalog Number
-
Brand Name
Wiltrom Spinal Fixation System
Version/Model Number
43545030 Polyaxial Pedicle Screw, Cannulated ø=5.0 L=30
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
K202894
Product Code
NKB
Product Code Name
Thoracolumbosacral Pedicle Screw System
Public Device Record Key
5c13d1bd-58b6-487f-be9d-86d2322cd647
Public Version Date
May 30, 2022
Public Version Number
1
DI Record Publish Date
May 20, 2022
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. | 77 |