LimaCorporate Kirschner Wire— 510(k) K203475

Substantially Equivalent

Lima Corporate S.P.A.

FDA 510(k) clearance K203475 for LimaCorporate Kirschner Wire, Substantially Equivalent on 2021-02-05. Applicant: Lima Corporate S.P.A.. Device class: 2.

Clearance details

Applicant
Lima Corporate S.P.A.
Product code
Code HTY
Device class
Class 2
Regulation
21 CFR 888.3040
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Villanova Di San Daniele Del Friuli, IT
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HTY

product code HTY
Injury
544
Total
544

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.