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FDA 510(k)

AFFINITY Proximal Tibia System

K-Number: K220199 · 2022-03-21

ApplicantTechfit Digital Surgery, Inc.
Decision Date2022-03-21
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AFFINITY Proximal Tibia System is a medical device manufactured by Techfit Digital Surgery, Inc.. It received FDA 510(k) clearance on 2022-03-21 under approval 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. It is manufactured by Techfit Digital Surgery, Inc.. The 510(k) number is K220199.

When was AFFINITY Proximal Tibia System approved by the FDA?

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

What company makes AFFINITY Proximal Tibia System?

AFFINITY Proximal Tibia System is manufactured by Techfit Digital Surgery, Inc..

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

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

Related Clinical Trials

NCT06472518 Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs. RECRUITING NCT07102160 Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking RECRUITING NCT07355270 A U.S. Pilot Human Investigation of RadiofrEquency Vapor Ablation System to Evaluate Safety, TOleRability, and Effectiveness for Proximal Intestinal Mucosal Ablation in Patients With Type 2 Diabetes Mellitus (RESTORE-1 Study) RECRUITING NCT07134257 Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Proximal Tibia Fractures RECRUITING

Other Devices by Techfit Digital Surgery, Inc.

K222577TECHFIT Diagnostic Models K242263TECHFIT DISRP® System K250297TECHFIT Patient-Specific Cranial System

Related Devices (Code: HRS)

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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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