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Cove Strip

by SeaSpine Orthopedics Corporation

510(k) K230486

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK230486 Date21 Aug 2023ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MQV
Device class
Class II
Regulation
21 CFR Part 888.3045
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cove Strip is a resorbable calcium salt bone void filler. It is designed to function as a filler for bone voids.

This device is classified as a Class II medical device under product code MQV. It has received FDA 510(k) clearance.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Cove Strip?

    The Cove Strip is specifically designed to act as a filler for bone voids. It is composed of a resorbable calcium salt material that integrates into the surgical site to support the filling of voids in bone tissue.

  • What is the regulatory status of the Cove Strip?

    The Cove Strip is classified as a Class II medical device under product code MQV. It has received FDA 510(k) clearance, which indicates that the device has been found to be substantially equivalent to a legally marketed predicate device.

  • What material is used in the construction of the Cove Strip?

    The device is manufactured using a resorbable calcium salt. This material is chosen for its ability to be resorbed by the body while serving its purpose as a bone void filler.