Bfix Orthopedic External Fixator Systems— 510(k) K200491

Name: FDA 510(k) clearance K200491
Creator: U.S. Food and Drug Administration
Published: 2021-01-05

Substantially Equivalent

Aike (Shanghai) Medical Instrument Co., Ltd.

FDA 510(k) clearance K200491 for Bfix Orthopedic External Fixator Systems, Substantially Equivalent on 2021-01-05. Applicant: Aike (Shanghai) Medical Instrument Co., Ltd.. Device class: 2.

Clearance details

Applicant: Aike (Shanghai) Medical Instrument Co., Ltd.
Product code: Code KTT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2020-02-28
Decision date: 2021-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code KTT

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K254087 — MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System2026-06-11
K260900 — DYNEX® External Fixation Systems2026-04-17
K260112 — QuikFix External Fixator: Knee-Spanning Pack2026-03-23
K253291 — Excelsior System2026-01-20
K253202 — Hoffmann LRF System2025-12-19

Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.