Cleared Traditional

Cove Putty, OsteoCove Putty

K231030 · SeaSpine Orthopedics Corporation · Orthopedic
Sep 2023
Decision
156d
Days
Class 2
Risk

About This 510(k) Submission

K231030 is an FDA 510(k) clearance for the Cove Putty, OsteoCove Putty, 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 September 14, 2023, 156 days after receiving the submission on April 11, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K231030 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2023
Decision Date September 14, 2023
Days to Decision 156 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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