WILTROM SPINAL FIXATION SYSTEM

GUDID 04719873024223

The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made 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.

WILTROM CO., LTD.

Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 04719873024223
• NIH Device Record Key: a8df2056-54e5-4cd7-93ba-4aa038f77f84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WILTROM SPINAL FIXATION SYSTEM
• Version Model Number: 43555035 Polyaxial Pedicle Screw ø=5.0 / L=35
• Company DUNS: 656680902
• Company Name: WILTROM CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: yichun@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw

Operating and Storage Conditions

• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719873024223 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172548

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

[04719873024223]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-18
• Device Publish Date: 2019-09-10

On-Brand Devices [WILTROM SPINAL FIXATION SYSTEM]

• 04719873024216: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024223: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024254: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024247: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873023790: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024841: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024834: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024827: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024810: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024803: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024797: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024780: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024773: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024766: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024759: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024742: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024735: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024728: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024711: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024704: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024698: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024681: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024674: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024667: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024650: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024643: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024636: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024209: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024193: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024186: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024179: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024162: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024155: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024148: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024131: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024124: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873027453: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873027446: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873027361: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024629: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024612: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024605: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024599: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024582: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024575: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024568: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024551: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024544: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024537: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ
• 04719873024520: The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associ