Cleared Traditional

K233607 - MagnetOs Easypack Putty (FDA 510(k) Clearance)

K233607 · Kuros Biosciences B.V · Orthopedic device

Dec 2023

Decision

36d

Days

Class 2

Risk

K233607 is an FDA 510(k) clearance for the MagnetOs Easypack Putty. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).

Submitted by Kuros Biosciences B.V (Bilthoven, NL). The FDA issued a Cleared decision on December 15, 2023, 36 days after receiving the submission on November 9, 2023.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number	K233607 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 09, 2023
Decision Date	December 15, 2023
Days to Decision	36 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF