K871323

Substantially Equivalent

ARTHROSCOPIC MENISCAL SUTURE SYSTEM

Applicant
Orthopedic Systems, Inc.
Product code
HWT
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hayward, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code HWT

product code HWT
Injury
218
Malfunction
12,907
Total
13,125

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.