Cove Strip, OsteoCove Strip
K-Number: K232668 · 2023-09-27
ApplicantSeaSpine Orthopedics Corporation
Decision Date2023-09-27
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Cove Strip, OsteoCove Strip is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2023-09-27 under approval number K232668. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cove Strip, OsteoCove Strip?
Cove Strip, OsteoCove Strip is a medical device that received FDA 510(k) clearance on 2023-09-27. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K232668.
When was Cove Strip, OsteoCove Strip approved by the FDA?
Cove Strip, OsteoCove Strip received FDA 510(k) clearance on 2023-09-27, under approval number K232668.
What company makes Cove Strip, OsteoCove Strip?
Cove Strip, OsteoCove Strip is manufactured by SeaSpine Orthopedics Corporation.
What is the FDA product code for Cove Strip, OsteoCove Strip?
The FDA product code for Cove Strip, OsteoCove Strip is MQV.
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
Related Devices (Code: MQV)
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.