ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX— 510(k) K080074

Substantially Equivalent

Ace Surgical Supply Co., Inc.

FDA 510(k) clearance K080074 for ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX, Substantially Equivalent on 2008-02-14. Applicant: Ace Surgical Supply Co., Inc..

Clearance details

Applicant: Ace Surgical Supply Co., Inc.
Product code: Code DZE
Advisory panel: Dental
Date received: 2008-01-11
Decision date: 2008-02-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Brockton, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

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.