DeviceClearance

REGENEREX TIBIAL COMPONENTS— 510(k) K080361

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K080361 for REGENEREX TIBIAL COMPONENTS, Substantially Equivalent on 2008-04-21. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant
Biomet, Inc.
Product code
Code MBH
Device class
Class 2
Regulation
21 CFR 888.3565
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 MBH

product code MBH
Injury
6,545
Malfunction
2,023
Total
8,568

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 K080361

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 K080361.

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