SYNDE-LOCK SYNDESMOSIS REPAIR KIT— 510(k) K111971

Substantially Equivalent

Tarsus Medical, Inc.

FDA 510(k) clearance K111971 for SYNDE-LOCK SYNDESMOSIS REPAIR KIT, Substantially Equivalent on 2012-01-23. Applicant: Tarsus Medical, Inc..

Clearance details

Applicant: Tarsus Medical, Inc.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2011-07-11
Decision date: 2012-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

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Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.