MSP METATARSAL SHORTENING SYSTEM— 510(k) K140724

Substantially Equivalent

Nextremity Solutions, Inc.

FDA 510(k) clearance K140724 for MSP METATARSAL SHORTENING SYSTEM, Substantially Equivalent on 2014-05-14. Applicant: Nextremity Solutions, Inc..

Clearance details

Applicant
Nextremity Solutions, Inc.
Product code
Code HRS
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Red Bank, NJ, US
Download summary PDFView 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, 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.