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FDA 510(k)

Orthopaedic Surgery Planning Software (AIJOINT)

K-Number: K233761 · 2024-08-05

ApplicantLongwood Valley Medical , Ltd.
Decision Date2024-08-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Orthopaedic Surgery Planning Software (AIJOINT) is the device name listed in this FDA 510(k) record. The listed applicant is Longwood Valley Medical , Ltd.. It received FDA 510(k) clearance on 2024-08-05 under 510(k) number K233761. 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 Orthopaedic Surgery Planning Software (AIJOINT)?

Orthopaedic Surgery Planning Software (AIJOINT) is a medical device that received FDA 510(k) clearance on 2024-08-05. The listed applicant is Longwood Valley Medical , Ltd.. The 510(k) number is K233761.

When did Orthopaedic Surgery Planning Software (AIJOINT) receive FDA 510(k) clearance?

Orthopaedic Surgery Planning Software (AIJOINT) received FDA 510(k) clearance on 2024-08-05, under 510(k) number K233761.

Who is the listed applicant for Orthopaedic Surgery Planning Software (AIJOINT)?

The FDA 510(k) record lists Longwood Valley Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Orthopaedic Surgery Planning Software (AIJOINT)?

The FDA product code for Orthopaedic Surgery Planning Software (AIJOINT) is LLZ.

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

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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