MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY— 510(k) K100618

Substantially Equivalent

Orthohelix Surgical Designs, Inc.

FDA 510(k) clearance K100618 for MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY, Substantially Equivalent on 2010-04-20. Applicant: Orthohelix Surgical Designs, Inc..

Clearance details

Applicant: Orthohelix Surgical Designs, Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2010-03-04
Decision date: 2010-04-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Medina, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.