MACROPORE PROTECTIVE SHEET (PROTEGO SYSTEM)— 510(k) K972913

Substantially Equivalent

Pacific Materials and Interfaces

FDA 510(k) clearance K972913 for MACROPORE PROTECTIVE SHEET (PROTEGO SYSTEM), Substantially Equivalent on 1998-07-30. Applicant: Pacific Materials and Interfaces.

Clearance details

Applicant: Pacific Materials and Interfaces
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 1997-08-07
Decision date: 1998-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.