DeviceClearance

BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES— 510(k) K073567

Substantially Equivalent

Zimmer GmbH

FDA 510(k) clearance K073567 for BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES, Substantially Equivalent on 2008-03-13. Applicant: Zimmer GmbH. Device class: 2.

Clearance details

Applicant
Zimmer GmbH
Product code
Code LZO
Device class
Class 2
Regulation
21 CFR 888.3353
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 LZO

product code LZO
Death
17
Injury
12,942
Malfunction
1,756
Total
14,715

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 K073567

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 K073567.

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