MODIFIED FREEMAN ACETABULAR CUP— 510(k) K902110

Substantially Equivalent

Turnkey Intergration USA, Inc.

FDA 510(k) clearance K902110 for MODIFIED FREEMAN ACETABULAR CUP, Substantially Equivalent on 1990-08-22. Applicant: Turnkey Intergration USA, Inc..

Clearance details

Applicant: Turnkey Intergration USA, Inc.
Product code: Code KWA
Advisory panel: Orthopedic
Date received: 1990-05-09
Decision date: 1990-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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Adverse events under product code KWA

product code KWA

Death: 38
Injury: 10,439
Malfunction: 1,862
Total: 12,339

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.