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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 a medical device manufactured by Longwood Valley Medical , Ltd.. It received FDA 510(k) clearance on 2024-08-05 under approval 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. It is manufactured by Longwood Valley Medical , Ltd.. The 510(k) number is K233761.

When was Orthopaedic Surgery Planning Software (AIJOINT) approved by the FDA?

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

What company makes Orthopaedic Surgery Planning Software (AIJOINT)?

Orthopaedic Surgery Planning Software (AIJOINT) is manufactured by Longwood Valley Medical , Ltd..

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

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

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Related PubMed Literature

PMID: 41915013 Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation. Clinical orthopaedics and related research (2026) PMID: 41543479 Ethical and Regulatory Considerations for Artificial Intelligence Adoption in Craniofacial Surgery. The Journal of craniofacial surgery () PMID: 41533265 Modernizing Medical Software Regulation in Bangladesh: A Roadmap for Risk-Based SaMD Oversight. Journal of medical systems (2026) PMID: 41513582 Medical devices for professional use: What assessment, what funding? Therapie (2026)

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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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