NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT— 510(k) K082672
Substantially EquivalentNovabone Products, LLC
FDA 510(k) clearance K082672 for NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT, Substantially Equivalent on 2008-12-09. 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
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.