DeviceClearance

COPELAND EAS HUMERAL RESURFACING HEADS— 510(k) K051843

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K051843 for COPELAND EAS HUMERAL RESURFACING HEADS, Substantially Equivalent on 2005-09-29. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant
Biomet, Inc.
Product code
Code HSD
Device class
Class 2
Regulation
21 CFR 888.3690
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Warsaw, IN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HSD

product code HSD
Injury
3,425
Malfunction
531
Total
3,956

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 →

Recalls naming K051843

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051843.

Data sourced from openFDA. This site is unofficial and independent of the FDA.