FITBONE(R) TAA

Rod, Fixation, Intramedullary And Accessories

WITTENSTEIN Intens GmbH

The following data is part of a premarket notification filed by Wittenstein Intens Gmbh with the FDA for Fitbone(r) Taa.

Pre-market Notification Details

• Device ID: K203399
• 510k Number: K203399
• Device Name: FITBONE(R) TAA
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: WITTENSTEIN Intens GmbH Walter-Wittensstein-StraBe 1 Igersheim, DE 97999
• Contact: Hartmut Kampa
• Correspondent: Cheryl Wagoner; Wagoner Consulting LLG P O Box 15729 Wilmington, NC 28408
• Product Code: HSB
• CFR Regulation Number: 888.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-11-19
• Decision Date: 2021-02-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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04260170144423	K203399	000