DeviceClearance

BIOPRO ZIRALLOY MODULAR FEMORAL HEADS— 510(k) K912641

Substantially Equivalent

Biopro, Inc.

FDA 510(k) clearance K912641 for BIOPRO ZIRALLOY MODULAR FEMORAL HEADS, Substantially Equivalent on 1991-11-27. Applicant: Biopro, Inc.. Device class: 2.

Clearance details

Applicant
Biopro, Inc.
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
Port Huron, MI, 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 K912641

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 K912641.

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