VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)— 510(k) K112837

Substantially Equivalent

Vilex, Inc.

FDA 510(k) clearance K112837 for VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE), Substantially Equivalent on 2012-10-09. Applicant: Vilex, Inc..

Clearance details

Applicant: Vilex, Inc.
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 2011-09-28
Decision date: 2012-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcminnville, TN, US

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Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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.