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FDA 510(k)

Cove Strip

K-Number: K230486 · 2023-08-21

ApplicantSeaSpine Orthopedics Corporation
Decision Date2023-08-21
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cove Strip is the device name listed in this FDA 510(k) record. The listed applicant is SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2023-08-21 under 510(k) number K230486. 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?

Cove Strip is a medical device that received FDA 510(k) clearance on 2023-08-21. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K230486.

When did Cove Strip receive FDA 510(k) clearance?

Cove Strip received FDA 510(k) clearance on 2023-08-21, under 510(k) number K230486.

Who is the listed applicant for Cove Strip?

The FDA 510(k) record lists SeaSpine Orthopedics Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cove Strip?

The FDA product code for Cove Strip is MQV.

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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.

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