MONOPOLY VC MP0220-5550

GUDID 04047844006115

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: 04047844006115
• NIH Device Record Key: 8fcd4799-22ad-4e5d-8e77-d36e777bf4a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MONOPOLY VC
• Version Model Number: Pedicle screw, cannulated, polyaxial
• Catalog Number: MP0220-5550
• 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
• 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
• 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
• 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	04047844006115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092073

FDA Product Code

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

Sterilization

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

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

[04047844006115]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-11-27
• Device Publish Date: 2014-08-31

On-Brand Devices [MONOPOLY VC]

• 04047844006306: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006290: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006283: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006276: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006269: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006252: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006245: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006238: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006221: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006214: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006207: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006191: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006184: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006177: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006160: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006153: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006146: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006139: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006122: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006115: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006108: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006092: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006085: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006078: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006061: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006054: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006047: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006030: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006023: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s
• 04047844006016: The MONOPOLY Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle s