WILTROM SPINAL FIXATION SYSTEM - The Wiltrom Spinal Fixation System is comprised - WILTROM CO., LTD.

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.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

WILTROM SPINAL FIXATION SYSTEM

Version/Model Number

43555035 Polyaxial Pedicle Screw ø=5.0 / L=35

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K172548,K202894

Product Code Details

Product Code

NKB

Product Code Name

Thoracolumbosacral Pedicle Screw System

Device Record Status

Public Device Record Key

a8df2056-54e5-4cd7-93ba-4aa038f77f84

Public Version Date

May 18, 2022

Public Version Number

3

DI Record Publish Date

September 10, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WILTROM CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 77