TTC Phantom Intramedullary Nail System— 510(k) K191782

Name: FDA 510(k) clearance K191782
Creator: U.S. Food and Drug Administration
Published: 2019-09-06

Substantially Equivalent

Paragon 28, Inc.

FDA 510(k) clearance K191782 for TTC Phantom Intramedullary Nail System, Substantially Equivalent on 2019-09-06. Applicant: Paragon 28, Inc.. Device class: 2.

Clearance details

Applicant: Paragon 28, Inc.
Product code: Product code HSB
Device class: Class 2
Regulation: 21 CFR 888.3020
Advisory panel: Orthopedic
Date received: 2019-07-02
Decision date: 2019-09-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

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K261651 — Precice Max System and Precice Ankle Salvage System2026-06-18

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Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

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.