DeviceClearance

ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES— 510(k) K083827

Substantially Equivalent

Biomet Manufacturing Corp

FDA 510(k) clearance K083827 for ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES, Substantially Equivalent on 2009-02-13. Applicant: Biomet Manufacturing Corp. Device class: 2.

Clearance details

Applicant
Biomet Manufacturing Corp
Product code
Code KRO
Device class
Class 2
Regulation
21 CFR 888.3510
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Warsaw, IN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KRO

product code KRO
Death
19
Injury
4,841
Total
4,860

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 K083827

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 K083827.

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