ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE— 510(k) K011087

Substantially Equivalent

Orthovita, Inc.

FDA 510(k) clearance K011087 for ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE, Substantially Equivalent on 2001-09-19. Applicant: Orthovita, Inc..

Clearance details

Applicant: Orthovita, Inc.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2001-04-10
Decision date: 2001-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malver, PA, US

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.