ASCOT HB-4318

GUDID 04047844026199

ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to accommodate anatomic requirements. Fixed and variable angle screws are available in numerous length/ diameter combinations. In addition, a center graft screw is offered.

SIGNUS Medizintechnik GmbH

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 04047844026199
• NIH Device Record Key: 259d740d-5e24-4820-a973-82b5d69b191b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASCOT
• Version Model Number: Variable angle screw, self drilling
• Catalog Number: HB-4318
• 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

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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04047844026199 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132310

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[04047844026199]

Moist Heat or Steam Sterilization

[04047844026199]

Moist Heat or Steam Sterilization

[04047844026199]

Moist Heat or Steam Sterilization

[04047844026199]

Moist Heat or Steam Sterilization

[04047844026199]

Moist Heat or Steam Sterilization

[04047844026199]

Moist Heat or Steam Sterilization

[04047844026199]

Moist Heat or Steam Sterilization

[04047844026199]

Moist Heat or Steam Sterilization

[04047844026199]

Moist Heat or Steam Sterilization

[04047844026199]

Moist Heat or Steam Sterilization

[04047844026199]

Moist Heat or Steam Sterilization

[04047844026199]

Moist Heat or Steam Sterilization

[04047844026199]

Moist Heat or Steam Sterilization

[04047844026199]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-21
• Device Publish Date: 2015-09-24

On-Brand Devices [ASCOT]

• 04047844026397: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026380: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026373: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026366: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026359: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026342: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026335: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026328: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026311: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026304: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026298: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026281: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026274: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026267: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026250: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026243: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026236: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026229: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026212: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026205: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026199: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026182: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026175: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026168: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026151: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026144: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026137: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026120: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026113: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026106: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026090: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026083: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026076: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026069: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026052: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026045: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026038: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026021: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026014: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844026007: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844025994: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844025987: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844025970: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844025963: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844025956: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844025949: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844025932: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844025925: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844025918: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to
• 04047844025901: ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to