Phantom Small Bone Intramedullary Nail System— 510(k) K170693

Substantially Equivalent

Paragon 28, Inc.

FDA 510(k) clearance K170693 for Phantom Small Bone Intramedullary Nail System, Substantially Equivalent on 2017-06-19. Applicant: Paragon 28, Inc..

Clearance details

Applicant: Paragon 28, Inc.
Product code: Code KTW
Advisory panel: Orthopedic
Date received: 2017-03-07
Decision date: 2017-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

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Adverse events under product code KTW

product code KTW

Injury: 220
Total: 220

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.