K071477

Substantially Equivalent

REVERTO 55 AND 37 SHAPE MEMORY STAPLES

Applicant: Core Essence Orthopaedics, LLC
Product code: JDR
Advisory panel: Orthopedic
Date received: 2007-05-29
Decision date: 2007-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yardley, PA, US

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.