Viper® Distal Volar Radius Plating System

FDA UDI

Class II (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name: Viper® Distal Volar Radius Plating System FDA UDI
Generic Name: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI
Device Name: 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. FDA UDI
Model / Reference: VIPERSET FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: VIPERSET FDA UDI
Primary DI / UDI-DI: 10381780064343 FDA UDI
510(k) Number: K041461 FDA UDI
FDA Product Code: HRS FDA UDI
GMDN Term: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Viper® Distal Volar Radius Plating System by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ascension Orthopedics, Inc.

Sources (1)

FDA UDI 1a71514e-65a9-498d-b2bd-e8810eddfc88 37 fields · synced May 30, 2026