NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE— 510(k) K140946
Substantially EquivalentNovabone Products, LLC
FDA 510(k) clearance K140946 for NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE, Substantially Equivalent on 2014-08-22. 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
- Traditional
- Location
- Alachua, FL, US
Recent devices under product code MQV
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view all- K242299 — NovaBone Putty - Synthetic Bioactive Bone Graft
- K240404 — NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)
- K220498 — NovoGen Wound Matrix
- K163310 — NovaBone IRM
- K152071 — NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only)
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.