LUBINUS SP II HIP SYSTEM— 510(k) K953653

Substantially Equivalent

Turnkey Intergration USA, Inc.

FDA 510(k) clearance K953653 for LUBINUS SP II HIP SYSTEM, Substantially Equivalent on 1995-11-06. Applicant: Turnkey Intergration USA, Inc..

Clearance details

Applicant: Turnkey Intergration USA, Inc.
Product code: Code JDG
Advisory panel: Orthopedic
Date received: 1995-08-03
Decision date: 1995-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDG

product code JDG

Injury: 804
Malfunction: 3,242
Total: 4,046

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.