BIOMET GRAFT DELIVERY SYRINGES— 510(k) K140710

Substantially Equivalent

Biomet Spine (Aka Ebi, LLC)

FDA 510(k) clearance K140710 for BIOMET GRAFT DELIVERY SYRINGES, Substantially Equivalent on 2014-09-04. Applicant: Biomet Spine (Aka Ebi, LLC).

Clearance details

Applicant: Biomet Spine (Aka Ebi, LLC)
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2014-03-21
Decision date: 2014-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, 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.