XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM— 510(k) K141697

Substantially Equivalent

Zimmer, Inc.

FDA 510(k) clearance K141697 for XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM, Substantially Equivalent on 2014-09-18. Applicant: Zimmer, Inc..

Clearance details

Applicant: Zimmer, Inc.
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2014-06-24
Decision date: 2014-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, 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.