GREAT TOE IMPLANT— 510(k) K021063

Substantially Equivalent

Signal Medical Corp.

FDA 510(k) clearance K021063 for GREAT TOE IMPLANT, Substantially Equivalent on 2002-07-01. Applicant: Signal Medical Corp..

Clearance details

Applicant
Signal Medical Corp.
Product code
Code KWD
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Port Huron, MI, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KWD

product code KWD
Injury
164
Total
164

Source: openFDA MAUDE database, through . 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.