CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW— 510(k) K141417

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K141417 for CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW, Substantially Equivalent on 2014-07-09. Applicant: Wrightmedicaltechnologyinc.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2014-05-29
Decision date: 2014-07-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.