CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM— 510(k) K051293

Substantially Equivalent

Ceremed , Inc.

FDA 510(k) clearance K051293 for CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM, Substantially Equivalent on 2005-06-14. Applicant: Ceremed , Inc..

Clearance details

Applicant: Ceremed , Inc.
Product code: Code JEY
Advisory panel: Dental
Date received: 2005-05-18
Decision date: 2005-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

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Adverse events under product code JEY

product code JEY

Injury: 1,542
Malfunction: 2,292
Total: 3,834

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.