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FDA 510(k)

Bfix Orthopedic External Fixator Systems

K-Number: K200491 · 2021-01-05

ApplicantAike (Shanghai) Medical Instrument Co., Ltd.
Decision Date2021-01-05
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Bfix Orthopedic External Fixator Systems is a medical device manufactured by Aike (Shanghai) Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2021-01-05 under approval number K200491. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bfix Orthopedic External Fixator Systems?

Bfix Orthopedic External Fixator Systems is a medical device that received FDA 510(k) clearance on 2021-01-05. It is manufactured by Aike (Shanghai) Medical Instrument Co., Ltd.. The 510(k) number is K200491.

When was Bfix Orthopedic External Fixator Systems approved by the FDA?

Bfix Orthopedic External Fixator Systems received FDA 510(k) clearance on 2021-01-05, under approval number K200491.

What company makes Bfix Orthopedic External Fixator Systems?

Bfix Orthopedic External Fixator Systems is manufactured by Aike (Shanghai) Medical Instrument Co., Ltd..

What is the FDA product code for Bfix Orthopedic External Fixator Systems?

The FDA product code for Bfix Orthopedic External Fixator Systems is KTT.

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Related PubMed Literature

PMID: 41613162 Evaluating Translational AI: A Two-Way Moving Target Problem. NEJM AI (2025) PMID: 41388920 Balancing Innovation and the Safe Introduction of Orthopedic Arthroplasty Implants to Market: The Ever-Evolving Regulatory Environment in Australia. Journal of orthopaedic research : official publication of the Orthopaedic Research Society (2026)

Related Devices (Code: KTT)

K160972Gexfix External FixationGexfix International Corp. K161753Hoffman LRF SystemStryker GmbH K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC K160830Integra External Fixation SystemAscension Orthopedics K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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