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FDA 510(k)

Virtu C Spinal Implant System

K-Number: K161649 · 2016-11-09

ApplicantMet 1 Technologies, LLC
Decision Date2016-11-09
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Virtu C Spinal Implant System is a medical device manufactured by Met 1 Technologies, LLC. It received FDA 510(k) clearance on 2016-11-09 under approval number K161649. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Virtu C Spinal Implant System?

Virtu C Spinal Implant System is a medical device that received FDA 510(k) clearance on 2016-11-09. It is manufactured by Met 1 Technologies, LLC. The 510(k) number is K161649.

When was Virtu C Spinal Implant System approved by the FDA?

Virtu C Spinal Implant System received FDA 510(k) clearance on 2016-11-09, under approval number K161649.

What company makes Virtu C Spinal Implant System?

Virtu C Spinal Implant System is manufactured by Met 1 Technologies, LLC.

What is the FDA product code for Virtu C Spinal Implant System?

The FDA product code for Virtu C Spinal Implant System is ODP.

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Related PubMed Literature

PMID: 39973146 Characterization of Spine Implant Device Recalls: A 21-Year Analysis. Spine (2026) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022) PMID: 33778409 Assessing the use of finite element analysis for mechanical performance evaluation of intervertebral body fusion devices. JOR spine (2021)

Other Devices by Met 1 Technologies, LLC

K160699VIRTU Lumbar Spacer System

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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