TENSYN BAND, TENSYN FRACTURE PLATES— 510(k) K141264

Substantially Equivalent

Dallen Medical, Inc.

FDA 510(k) clearance K141264 for TENSYN BAND, TENSYN FRACTURE PLATES, Substantially Equivalent on 2014-08-21. Applicant: Dallen Medical, Inc..

Clearance details

Applicant: Dallen Medical, Inc.
Product code: Code HTN
Advisory panel: Orthopedic
Date received: 2014-05-15
Decision date: 2014-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, 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.