Viper® Distal Volar Radius Plating System VIPERSET

GUDID M268VIPERSET0

The VIPERSET consists of a distal volar radius plate with the option of either a 4-hole or 6-hole plate with left or right configuration, screws in diameter size 2.7mm or 3.5mm, and instruments to assist in the implantation. The set is generally indicated for reduction, stabilization and internal fixation of proximal radius bone fractures and osteotomies involving the distal radius.

Ascension Orthopedics, Inc.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: M268VIPERSET0
• NIH Device Record Key: 1a71514e-65a9-498d-b2bd-e8810eddfc88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Viper® Distal Volar Radius Plating System
• Version Model Number: VIPERSET
• Catalog Number: VIPERSET
• Company DUNS: 942377524
• Company Name: Ascension Orthopedics, Inc.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780064343 [Primary]
HIBCC	M268VIPERSET0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041461

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

[M268VIPERSET0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-03-04
• Device Publish Date: 2015-08-15

On-Brand Devices [Viper® Distal Volar Radius Plating System]

• M2486000111: 1.1MM K-WIRE
• M2486050271: VIPER/VALT 2.7MM DRILL BIT
• M2486050201: VIPER/VALT 2.0MM DRILL BIT
• M2486050021: VALT KEY LOCK DRIVER
• M2486050011: VALT PLACEMENT DRIVER
• M248281350161: The Viper cortical titanium screw, which is placed proximally.
• M248281350121: The Viper cortical titanium screw, which is placed proximally.
• M248280066011: The Viper distal volar radius plate consists of six holes with left to right configuration.
• M248280064011: The Viper distal volar radius plate consists of four holes with left to right configuration.
• M248271427301: The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distally.
• M248271427201: The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distally.
• M248271427181: The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distally.
• M248271427161: The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distally.
• M248271427121: The Viper Variable Angle Locking Technology (VALT) titanium screw, which is placed distally.
• M268VIPERSET0: The VIPERSET consists of a distal volar radius plate with the option of either a 4-hole or 6-hol