Cleared Traditional

Cove Putty, OsteoCove Putty

K242273 · SeaSpine Orthopedics Corporation · Orthopedic
Sep 2024
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K242273 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 (Carlsbad, US). The FDA issued a Cleared decision on September 25, 2024, 55 days after receiving the submission on August 1, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K242273 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2024
Decision Date September 25, 2024
Days to Decision 55 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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