TenoTac Soft Tissue Fixation System— 510(k) K203385

Substantially Equivalent

Paragon 28, Inc.

FDA 510(k) clearance K203385 for TenoTac Soft Tissue Fixation System, Substantially Equivalent on 2021-02-11. Applicant: Paragon 28, Inc..

Clearance details

Applicant: Paragon 28, Inc.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2020-11-18
Decision date: 2021-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

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Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.