Mg OSTEOREVIVE, Mg OSTEOCRETE— 510(k) K242372

Substantially Equivalent

Bone Solutions, Inc.

FDA 510(k) clearance K242372 for Mg OSTEOREVIVE, Mg OSTEOCRETE, Substantially Equivalent on 2024-10-18. Applicant: Bone Solutions, Inc.. Device class: 2.

Clearance details

Applicant
Bone Solutions, Inc.
Product code
Code MQV
Device class
Class 2
Regulation
21 CFR 888.3045
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Colleyville, TX, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MQV

product code MQV
Death
6
Injury
435
Total
441

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.