Dolphix® External Fixation System MR Conditional— 510(k) K163323

Substantially Equivalent

Citieffe S.R.L.

FDA 510(k) clearance K163323 for Dolphix® External Fixation System MR Conditional, Substantially Equivalent on 2017-03-20. Applicant: Citieffe S.R.L..

Clearance details

Applicant: Citieffe S.R.L.
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2016-11-25
Decision date: 2017-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Calderara Di Reno, IT

Download summary PDF View on FDA.gov ↗

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.