CONSENSUS ACETABULAR SHELL SYSTEM— 510(k) K060635

Substantially Equivalent

Hayes Medical, Inc.

FDA 510(k) clearance K060635 for CONSENSUS ACETABULAR SHELL SYSTEM, Substantially Equivalent on 2006-04-28. Applicant: Hayes Medical, Inc..

Clearance details

Applicant: Hayes Medical, Inc.
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 2006-03-10
Decision date: 2006-04-28
Decision: Substantially Equivalent
Clearance type: Special
Location: El Dorado Hills, CA, US

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Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

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.