A.M. Surgical Intramedullary Fixation Device— 510(k) K180087

Substantially Equivalent

A.M. Surgical, Inc.

FDA 510(k) clearance K180087 for A.M. Surgical Intramedullary Fixation Device, Substantially Equivalent on 2018-05-18. Applicant: A.M. Surgical, Inc..

Clearance details

Applicant: A.M. Surgical, Inc.
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 2018-01-12
Decision date: 2018-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Smithtown, NY, US

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Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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.