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FDA 510(k)

TECHFIT Diagnostic Models

K-Number: K222577 · 2023-01-06

ApplicantTechfit Digital Surgery, Inc.
Decision Date2023-01-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TECHFIT Diagnostic Models is a medical device manufactured by Techfit Digital Surgery, Inc.. It received FDA 510(k) clearance on 2023-01-06 under approval number K222577. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECHFIT Diagnostic Models?

TECHFIT Diagnostic Models is a medical device that received FDA 510(k) clearance on 2023-01-06. It is manufactured by Techfit Digital Surgery, Inc.. The 510(k) number is K222577.

When was TECHFIT Diagnostic Models approved by the FDA?

TECHFIT Diagnostic Models received FDA 510(k) clearance on 2023-01-06, under approval number K222577.

What company makes TECHFIT Diagnostic Models?

TECHFIT Diagnostic Models is manufactured by Techfit Digital Surgery, Inc..

What is the FDA product code for TECHFIT Diagnostic Models?

The FDA product code for TECHFIT Diagnostic Models is LLZ.

Related Clinical Trials

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Related PubMed Literature

PMID: 34161248 Possible Contexts of Use for In Silico Trials Methodologies: A Consensus-Based Review. IEEE journal of biomedical and health informatics (2021)

Other Devices by Techfit Digital Surgery, Inc.

K220199AFFINITY Proximal Tibia System K242263TECHFIT DISRP® System K250297TECHFIT Patient-Specific Cranial System

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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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