PORE-SI BONE GRAFT SUBSTITUTE— 510(k) K040082
Substantially EquivalentApatech , Ltd.
FDA 510(k) clearance K040082 for PORE-SI BONE GRAFT SUBSTITUTE, Substantially Equivalent on 2004-08-04. Applicant: Apatech , Ltd.. Device class: 2.
Clearance details
- Applicant
- Apatech , Ltd.
- 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
- Abbreviated
- Location
- Waltham, MA, US
Recent devices under product code MQV
view allMore clearances from Apatech , Ltd.
view all- K090850 — ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE
- K082575 — ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES
- K081979 — ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE
- K082073 — ACTIFUSE FLOW BONE GRAFT SUBSTITUTE
- K080736 — ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE
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.