SURFACE REPLACEMENT HIP PROSTHESIS— 510(k) K811718

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K811718 for SURFACE REPLACEMENT HIP PROSTHESIS, Substantially Equivalent on 1981-09-18. Applicant: Biomet, Inc..

Clearance details

Applicant: Biomet, Inc.
Product code: Code KYB
Advisory panel: Ophthalmic
Date received: 1981-06-18
Decision date: 1981-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KYB

product code KYB

Injury: 218
Malfunction: 1,989
Other: 1
Total: 2,208

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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