Cleared Traditional

Cove Strip

K230486 · SeaSpine Orthopedics Corporation · Orthopedic
Aug 2023
Decision
179d
Days
Class 2
Risk

About This 510(k) Submission

K230486 is an FDA 510(k) clearance for the Cove Strip, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by SeaSpine Orthopedics Corporation (Irvine, US). The FDA issued a Cleared decision on August 21, 2023, 179 days after receiving the submission on February 23, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K230486 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 2023
Decision Date August 21, 2023
Days to Decision 179 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MQV — Filler, Bone Void, Calcium Compound
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3045

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