CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM— 510(k) K946165

Substantially Equivalent

Elekta Instruments, Inc.

FDA 510(k) clearance K946165 for CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM, Substantially Equivalent on 1995-05-23. Applicant: Elekta Instruments, Inc..

Clearance details

Applicant: Elekta Instruments, Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 1994-12-19
Decision date: 1995-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.