Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FITBONE(R) TAA

K-Number: K203399 · 2021-02-17

ApplicantWittenstein Intens GmbH
Decision Date2021-02-17
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FITBONE(R) 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 2021-02-17 under 510(k) number K203399. 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(R) TAA?

FITBONE(R) TAA is a medical device that received FDA 510(k) clearance on 2021-02-17. The listed applicant is Wittenstein Intens GmbH. The 510(k) number is K203399.

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

FITBONE(R) TAA received FDA 510(k) clearance on 2021-02-17, under 510(k) number K203399.

Who is the listed applicant for FITBONE(R) 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(R) TAA?

The FDA product code for FITBONE(R) TAA is HSB.

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.

K163368FITBONE 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

View on FDA Database →

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

↑