ALTES BUTTRESS PLATING SYSTEM— 510(k) K061482

Substantially Equivalent

Altiva Corp.

FDA 510(k) clearance K061482 for ALTES BUTTRESS PLATING SYSTEM, Substantially Equivalent on 2006-07-26. Applicant: Altiva Corp..

Clearance details

Applicant
Altiva Corp.
Product code
Code KWQ
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Charlotte, NC, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KWQ

product code KWQ
Death
8
Injury
1,212
Malfunction
1,233
Total
2,453

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.