ALLOFIX PUSH-IN ANCHOR— 510(k) K070347

Substantially Equivalent

Musculoskeletal Transplant Foundation

FDA 510(k) clearance K070347 for ALLOFIX PUSH-IN ANCHOR, Substantially Equivalent on 2007-05-11. Applicant: Musculoskeletal Transplant Foundation.

Clearance details

Applicant
Musculoskeletal Transplant Foundation
Product code
Code HWC
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Edison, NJ, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HWC

product code HWC
Death
20
Injury
15,910
Malfunction
8,192
Other
1
Total
24,123

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.