MOORE TYPE ENDO PROSTHESIS— 510(k) K900051

Substantially Equivalent

Lima Intl. Corp.

FDA 510(k) clearance K900051 for MOORE TYPE ENDO PROSTHESIS, Substantially Equivalent on 1990-10-03. Applicant: Lima Intl. Corp.. Device class: 2.

Clearance details

Applicant
Lima Intl. Corp.
Product code
Code KWY
Device class
Class 2
Regulation
21 CFR 888.3390
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
E Providence, RI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KWY

product code KWY
Death
3
Injury
2,049
Total
2,052

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.