HammerToe Compression System— 510(k) K183228

Substantially Equivalent

Paragon 28, Inc.

FDA 510(k) clearance K183228 for HammerToe Compression System, Substantially Equivalent on 2019-01-25. Applicant: Paragon 28, Inc..

Clearance details

Applicant: Paragon 28, Inc.
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 2018-11-20
Decision date: 2019-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, 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.