SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM— 510(k) K122455

Substantially Equivalent

Synthes

FDA 510(k) clearance K122455 for SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM, Substantially Equivalent on 2013-04-11. Applicant: Synthes.

Clearance details

Applicant: Synthes
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2012-08-13
Decision date: 2013-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

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Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.