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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 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 2023-01-06 under 510(k) 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. The listed applicant is Techfit Digital Surgery, Inc.. The 510(k) number is K222577.

When did TECHFIT Diagnostic Models receive FDA 510(k) clearance?

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

Who is the listed applicant for TECHFIT Diagnostic Models?

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 TECHFIT Diagnostic Models?

The FDA product code for TECHFIT Diagnostic Models is LLZ.

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: LLZ)

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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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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