SeaSpine Ventura NanoMetalene System
K-Number: K173022 · 2017-10-26
ApplicantSeaSpine Orthopedics Corporation
Decision Date2017-10-26
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SeaSpine Ventura NanoMetalene System is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2017-10-26 under approval number K173022. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SeaSpine Ventura NanoMetalene System?
SeaSpine Ventura NanoMetalene System is a medical device that received FDA 510(k) clearance on 2017-10-26. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K173022.
When was SeaSpine Ventura NanoMetalene System approved by the FDA?
SeaSpine Ventura NanoMetalene System received FDA 510(k) clearance on 2017-10-26, under approval number K173022.
What company makes SeaSpine Ventura NanoMetalene System?
SeaSpine Ventura NanoMetalene System is manufactured by SeaSpine Orthopedics Corporation.
What is the FDA product code for SeaSpine Ventura NanoMetalene System?
The FDA product code for SeaSpine Ventura NanoMetalene System is MAX.
Other Devices by SeaSpine Orthopedics Corporation
K162351SeaSpine® Vu aPOD Prime NanoMetalene® Intervertebral Body Fusion Device
K162715SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene
K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone System
K161535SeaSpine® NewPort Spinal System
K160902Mariner Pedicle Screw System
K172926SeaSpine Vu cPOD, Zuma-C, Complete Cervical
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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.