BONE SCREWS— 510(k) K843554

Substantially Equivalent

Mecron Medical Products, Inc.

FDA 510(k) clearance K843554 for BONE SCREWS, Substantially Equivalent on 1984-10-01. Applicant: Mecron Medical Products, Inc..

Clearance details

Applicant: Mecron Medical Products, Inc.
Product code: Code KTW
Advisory panel: Orthopedic
Date received: 1984-09-10
Decision date: 1984-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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.