510(k) Report

FDA applicant

Turnkey Intergration USA, Inc.

Indianapolis, IN26 decisions1990–19995 recalls

FDA records 26 decisions for Turnkey Intergration USA, Inc. (Indianapolis, IN) from 1990 to 1999: 26 510(k) clearances. Most are in product codes LWJ (Prosthesis, Hip, Semi-Constrained…) and LZO (Prosthesis, Hip, Semi-Constrained…). 5 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Turnkey Intergration USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Turnkey Intergration USA, Inc. since 2007.

Recalls per year

1in 2025

2024: 42025: 1
2007high 4 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Turnkey Intergration USA, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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