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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 the device name listed in this FDA 510(k) record. The listed applicant is Aike (Shanghai) Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2021-01-05 under 510(k) 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. The listed applicant is Aike (Shanghai) Medical Instrument Co., Ltd.. The 510(k) number is K200491.

When did Bfix Orthopedic External Fixator Systems receive FDA 510(k) clearance?

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

Who is the listed applicant for Bfix Orthopedic External Fixator Systems?

The FDA 510(k) record lists Aike (Shanghai) Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: KTT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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