TREACE MAGNUM OTO-TOOL SYSTEM— 510(k) K873154

Substantially Equivalent

Treace Medical, Inc.

FDA 510(k) clearance K873154 for TREACE MAGNUM OTO-TOOL SYSTEM, Substantially Equivalent on 1987-09-04. Applicant: Treace Medical, Inc..

Clearance details

Applicant: Treace Medical, Inc.
Product code: Code ERL
Advisory panel: Ear, Nose, Throat
Date received: 1987-08-11
Decision date: 1987-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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Adverse events under product code ERL

product code ERL

Malfunction: 11,234
Total: 11,234

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.