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FDA 510(k)

FITBONE TAA

K-Number: K163368 · 2017-01-26

ApplicantWittenstein Intens GmbH
Decision Date2017-01-26
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FITBONE TAA is the device name listed in this FDA 510(k) record. The listed applicant is Wittenstein Intens GmbH. It received FDA 510(k) clearance on 2017-01-26 under 510(k) number K163368. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FITBONE TAA?

FITBONE TAA is a medical device that received FDA 510(k) clearance on 2017-01-26. The listed applicant is Wittenstein Intens GmbH. The 510(k) number is K163368.

When did FITBONE TAA receive FDA 510(k) clearance?

FITBONE TAA received FDA 510(k) clearance on 2017-01-26, under 510(k) number K163368.

Who is the listed applicant for FITBONE TAA?

The FDA 510(k) record lists Wittenstein Intens GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FITBONE TAA?

The FDA product code for FITBONE TAA is HSB.

Related Clinical Trials

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.

NCT06400732Post Market Evaluation of Clinical Safety and Performance of the Fitbone Transport and Lengthening SystemTERMINATED

Other records listing Wittenstein Intens GmbH as applicant

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.

K203399FITBONE(R) TAA

Related Devices (Code: HSB)

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.

K261481Pangea Femur Reconstruction SystemStryker GmbHK261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix Srl

Official Source

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

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