DeviceClearance

UNITED 36MM CERAMIC FEMORAL HEAD, DELTA— 510(k) K112463

Substantially Equivalent

United Orthopedic Corporation

FDA 510(k) clearance K112463 for UNITED 36MM CERAMIC FEMORAL HEAD, DELTA, Substantially Equivalent on 2011-09-23. Applicant: United Orthopedic Corporation. Device class: 2.

Clearance details

Applicant
United Orthopedic Corporation
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
Special
Location
Hsinchu, TW
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 K112463

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 K112463.

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