APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)— 510(k) K954800

Substantially Equivalent for Some Indications

Intermedics Orthopedics

FDA 510(k) clearance K954800 for APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI), Substantially Equivalent for Some Indications on 1996-04-25. Applicant: Intermedics Orthopedics.

Clearance details

Applicant: Intermedics Orthopedics
Product code: Code MEH
Advisory panel: Orthopedic
Date received: 1995-09-27
Decision date: 1996-04-25
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Austin, TX, US

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Adverse events under product code MEH

product code MEH

Injury: 2,021
Total: 2,021

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.