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Viper Spine System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K102701

by Depuy Spine, Inc.

Identifiers

510(k) Number
K102701 FDA 510(k)
FDA Product Code
NKB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3070 FDA 510(k)
Regulation Number
888.3070 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The VIPER 2 MIS Spine System is a minimally invasive spine surgery platform designed for the treatment of degenerative and complex spinal conditions. It includes a range of instrumentation and implant options tailored for procedures requiring reduced invasiveness while maintaining precision and control. This system is classified under orthopedic devices and is intended for spinal interventions where less invasive techniques are preferred. Its modular design supports a variety of spinal pathologies, from degenerative cases to more advanced indications.

The VIPER 2 MIS Spine System is supplied as a comprehensive surgical solution, combining tools and implants for minimally invasive procedures. It is intended for single-use or reusable components as specified by the manufacturer, though sterility and reuse instructions must be followed per facility protocols. The system adheres to FDA clearance under 510(k) number K102701, with a special review designation under the orthopedic advisory committee. Storage and handling must comply with regulatory and manufacturer guidelines to ensure device integrity and safety.

Frequently asked questions

What is the VIPER 2 MIS Spine System used for?

The VIPER 2 MIS Spine System is designed for minimally invasive spine surgery to treat degenerative and complex spinal conditions. Its modular instrumentation and implant options allow surgeons to perform procedures with reduced invasiveness while maintaining precision and control, making it suitable for a range of spinal pathologies, from degenerative cases to more advanced indications.

How is the VIPER 2 MIS Spine System supplied?

The system is supplied as a comprehensive surgical solution, including tools and implants tailored for minimally invasive procedures. Components may be used either as single-use or reusable items, depending on facility protocols and manufacturer guidelines. Sterility and reuse instructions must be strictly followed to ensure safety and device integrity.

Is the VIPER 2 MIS Spine System sterile upon delivery?

The sterility of the VIPER 2 MIS Spine System components depends on their intended use (single-use or reusable). Single-use items are typically sterile upon delivery, while reusable components require proper sterilization procedures as outlined by the manufacturer and facility protocols before use. Always verify sterility status and follow handling instructions to maintain compliance.

What regulatory approval does the VIPER 2 MIS Spine System hold?

The VIPER 2 MIS Spine System holds FDA clearance under 510(k) number K102701, with a special review designation under the Orthopedic Advisory Committee. This clearance confirms its substantial equivalence to a predicate device and compliance with U.S. regulatory standards for orthopedic spine systems.

How should the VIPER 2 MIS Spine System be stored?

Storage of the VIPER 2 MIS Spine System must comply with manufacturer guidelines and regulatory requirements to preserve device integrity and safety. Single-use items should be stored in their original packaging in a clean, dry environment, protected from contamination. Reusable components require proper cleaning, sterilization, and storage procedures as specified by the manufacturer to ensure they remain functional and safe for repeated use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: VIPER 2 MIS Spine System | Products | DePuy Synthes, VIPER® 2 MIS Spine System - SPINEMarketGroup, PDF MIS Spine System Adaptable MIS solutions for an evolving practice

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Depuy Spine, Inc.

Sources (1)

  • FDA 510(k) K102701 24 fields · synced Oct 5, 2026