DeviceClearance

BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL— 510(k) K091976

Substantially Equivalent

Biomet Trauma

FDA 510(k) clearance K091976 for BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL, Substantially Equivalent on 2009-08-17. Applicant: Biomet Trauma. Device class: 2.

Clearance details

Applicant
Biomet Trauma
Product code
Code HSB
Device class
Class 2
Regulation
21 CFR 888.3020
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Parsippany, NJ, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HSB

product code HSB
Death
49
Injury
12,083
Malfunction
6,561
Other
1
Total
18,694

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 K091976

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 K091976.

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