VIPER PRIME Additions to the VIPER System
510(k) K162912
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK162912 | Date8 Dec 2016 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 25 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- NKB
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Viper Prime Additions to the Viper System is a modular orthopedic surgical instrument designed to complement the Viper System for spinal and orthopedic procedures. These additions enhance functionality for tasks such as screw insertion, reduction, and fixation in spinal surgeries, providing precision and stability during surgical interventions.
The device is supplied as a reusable surgical instrument set, intended for use in sterile operating room environments. It is classified under the product code NKB and is authorized under FDA 510K clearance and MDR compliance. No specific MRI safety classification or single-use designation is noted in the data.
Other devices from Medos International SARL
Questions
AI-generated answers, 18 Sep 2026
What types of surgical procedures is the Viper Prime designed to assist with, and how does it enhance the existing Viper System?
The Viper Prime additions are modular orthopedic surgical instruments designed to complement the Viper System for spinal and orthopedic procedures, specifically improving precision and stability during tasks like screw insertion, reduction, and fixation. These additions expand the Viper System’s capabilities by providing specialized tools tailored for complex surgical interventions, ensuring better control and accuracy in critical steps.
Is the Viper Prime set intended for single-use or reusable applications, and how should it be handled in the operating room?
The Viper Prime additions are supplied as a reusable surgical instrument set, meaning they are meant for repeated use after proper cleaning, sterilization, and maintenance. Since they are designed for sterile operating room environments, they must be processed according to standard surgical instrument protocols to ensure sterility and functionality between procedures.
What regulatory pathways has the Viper Prime followed for approval, and which advisory committee was involved in its review?
The Viper Prime additions were cleared through the FDA 510(k) process under the Orthopedic (OR) Advisory Committee, with a decision date of December 8, 2016. The device was classified under product code NKB and determined to be substantially equivalent to a predicate device. Additionally, it complies with MDR (Medical Device Regulation) standards as noted in the authorization data.
Are there different sizes or models available for the Viper Prime additions, and if so, how might they be selected for a specific procedure?
The provided data does not specify individual sizes or models for the Viper Prime additions, but as a modular system, it is likely designed to accommodate various spinal and orthopedic applications. Selection would typically depend on the surgeon’s preference, procedural requirements, and compatibility with the existing Viper System components. For precise sizing, consulting the manufacturer’s technical documentation or a surgical specialist is recommended.