MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM— 510(k) K052037

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K052037 for MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM, Substantially Equivalent on 2005-08-05. Applicant: Howmedica Osteonics Corp..

Clearance details

Applicant: Howmedica Osteonics Corp.
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2005-07-28
Decision date: 2005-08-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Mahwah, NJ, 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.