NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)— 510(k) K240404

Substantially Equivalent

Novabone Products, LLC

FDA 510(k) clearance K240404 for NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615), Substantially Equivalent on 2024-03-05. Applicant: Novabone Products, LLC. Device class: 2.

Clearance details

Applicant
Novabone Products, LLC
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
Special
Location
Alachua, FL, 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.