MONOPOLY/CONKLUSION 120080A

GUDID 04047844007129

The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws sizes, couplers, a set screw, cross links, a washer, rods and hooks. All implantable components are manufactured from medical grade titanium alloy (Ti-6AL-4V-Eli).

SIGNUS Medizintechnik GmbH

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 04047844007129
• NIH Device Record Key: 44b643b2-5d59-43d5-9034-8699e99c1799
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MONOPOLY/CONKLUSION
• Version Model Number: Rod, straight
• Catalog Number: 120080A
• Company DUNS: 344203948
• Company Name: SIGNUS Medizintechnik GmbH
• 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: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04047844007129 [Primary]

FDA Product Code

• NKB: Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Sterilization

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

[04047844007129]

Moist Heat or Steam Sterilization

[04047844007129]

Moist Heat or Steam Sterilization

[04047844007129]

Moist Heat or Steam Sterilization

[04047844007129]

Moist Heat or Steam Sterilization

[04047844007129]

Moist Heat or Steam Sterilization

[04047844007129]

Moist Heat or Steam Sterilization

[04047844007129]

Moist Heat or Steam Sterilization

[04047844007129]

Moist Heat or Steam Sterilization

[04047844007129]

Moist Heat or Steam Sterilization

[04047844007129]

Moist Heat or Steam Sterilization

[04047844007129]

Moist Heat or Steam Sterilization

[04047844007129]

Moist Heat or Steam Sterilization

[04047844007129]

Moist Heat or Steam Sterilization

[04047844007129]

Moist Heat or Steam Sterilization

[04047844007129]

Moist Heat or Steam Sterilization

[04047844007129]

Moist Heat or Steam Sterilization

[04047844007129]

Moist Heat or Steam Sterilization

[04047844007129]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-11-27
• Device Publish Date: 2014-08-31

On-Brand Devices [MONOPOLY/CONKLUSION]

• 04047844008225: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, scre
• 04047844008218: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, scre
• 04047844008201: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, scre
• 04047844008195: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, scre
• 04047844008188: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, scre
• 04047844008171: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, scre
• 04047844008164: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, scre
• 04047844008157: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, scre
• 04047844008140: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, scre
• 04047844008133: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, scre
• 04047844008126: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, scre
• 04047844008119: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, scre
• 04047844008102: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, scre
• 04047844008096: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, scre
• 04047844008089: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, scre
• 04047844008072: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, scre
• 04047844008065: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, scre
• 04047844007259: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844007242: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844007235: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844007228: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844007211: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844007204: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844007198: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844007181: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844007174: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844007167: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844007150: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844007143: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844007136: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844007129: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844007112: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844007105: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844007099: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844007082: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844007075: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844007068: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844007051: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844007044: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844007037: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844007020: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844039977: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, scre
• 04047844039960: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, scre
• 04047844039953: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, scre
• 04047844039946: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, scre
• 04047844039939: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, scre
• 04047844006924: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, scre
• 04047844006917: The CONKLUSION Pedicle Screw System is a spinal system that consists of a variety of hooks, scre
• 04047844007273: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844007266: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s