FDA 510(k)

AFFINITY Proximal Tibia System

K-Number: K220199 · 2022-03-21

Decision Date2022-03-21

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

AFFINITY Proximal Tibia System is the device name listed in this FDA 510(k) record. The listed applicant is Techfit Digital Surgery, Inc.. It received FDA 510(k) clearance on 2022-03-21 under 510(k) number K220199. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AFFINITY Proximal Tibia System?

AFFINITY Proximal Tibia System is a medical device that received FDA 510(k) clearance on 2022-03-21. The listed applicant is Techfit Digital Surgery, Inc.. The 510(k) number is K220199.

When did AFFINITY Proximal Tibia System receive FDA 510(k) clearance?

AFFINITY Proximal Tibia System received FDA 510(k) clearance on 2022-03-21, under 510(k) number K220199.

Who is the listed applicant for AFFINITY Proximal Tibia System?

The FDA 510(k) record lists Techfit Digital Surgery, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AFFINITY Proximal Tibia System?

The FDA product code for AFFINITY Proximal Tibia System is HRS.

Other records listing Techfit Digital Surgery, Inc. 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.

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Related Devices (Code: HRS)

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip Technics K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip Technics K261054RibPlate SystemStryker Leibinger GmbH & Co KG

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.