Cleared Traditional

K221256 - Mg OSTEOINJECT
(FDA 510(k) Clearance)

K221256 · Bone Solutions, Inc. · Orthopedic

Jun 2022

Decision

57d

Days

Class 2

Risk

K221256 is an FDA 510(k) clearance for the Mg OSTEOINJECT, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Bone Solutions, Inc. (Colleyville, US). The FDA issued a Cleared decision on June 28, 2022, 57 days after receiving the submission on May 2, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number	K221256 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 2022
Decision Date	June 28, 2022
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF