TruShot with Y-Knot Shallow All-Suture Anchor— 510(k) K182439

Substantially Equivalent

Conmed Corporation

FDA 510(k) clearance K182439 for TruShot with Y-Knot Shallow All-Suture Anchor, Substantially Equivalent on 2019-01-08. Applicant: Conmed Corporation.

Clearance details

Applicant: Conmed Corporation
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2018-09-07
Decision date: 2019-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Utica, NY, US

Download summary PDF View on FDA.gov ↗

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.