OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC,— 510(k) K121989

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K121989 for OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC,, Substantially Equivalent on 2012-11-27. Applicant: Exactech, Inc..

Clearance details

Applicant: Exactech, Inc.
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2012-07-06
Decision date: 2012-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

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Adverse events under product code MQV

product code MQV

Death: 6
Injury: 435
Total: 441

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.