REPROCESSED EXTERNAL FIXATION DEVICE— 510(k) K023714

Substantially Equivalent

Alliance Medical Corp.

FDA 510(k) clearance K023714 for REPROCESSED EXTERNAL FIXATION DEVICE, Substantially Equivalent on 2003-02-03. Applicant: Alliance Medical Corp..

Clearance details

Applicant
Alliance Medical Corp.
Product code
Code KTT
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Phoenix, AZ, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KTT

product code KTT
Death
11
Injury
3,097
Malfunction
1,261
Total
4,369

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.