HIP PLATE REMOVAL INSTRUMENT— 510(k) K780300

Substantially Equivalent

Richard'S Medical Equip., Inc.

FDA 510(k) clearance K780300 for HIP PLATE REMOVAL INSTRUMENT, Substantially Equivalent on 1978-02-28. Applicant: Richard'S Medical Equip., Inc..

Clearance details

Applicant
Richard'S Medical Equip., Inc.
Product code
Code HWB
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HWB

product code HWB
Malfunction
1,893
Total
1,893

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.