ORTHOHELIX SYNDESMOSIS FIXATION DEVICES— 510(k) K132733

Substantially Equivalent

Orthohelix Surgical Designs, Inc.

FDA 510(k) clearance K132733 for ORTHOHELIX SYNDESMOSIS FIXATION DEVICES, Substantially Equivalent on 2014-01-03. Applicant: Orthohelix Surgical Designs, Inc..

Clearance details

Applicant: Orthohelix Surgical Designs, Inc.
Product code: Code HTN
Advisory panel: Orthopedic
Date received: 2013-09-03
Decision date: 2014-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medina, OH, US

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Adverse events under product code HTN

product code HTN

Injury: 310
Malfunction: 639
Total: 949

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.