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Parker Quality & Compliance

PQC Reg Watch

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510(k) clearance

Mg OSTEOREVIVE™;Mg OSTEOCRETE™

FDA 510(k) source

510(k) number
K262230
Applicant
Bone Solutions, Inc.
Decision date
Sep 11, 2026
Date received
Jun 30, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
MQV
Device type
Filler, Bone Void, Calcium Compound
Device class
Class II
Regulation
21 CFR 888.3045
Advisory committee
Orthopedic
Statement or summary
Summary
Third party
N
Location
Colleyville, TX, US