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FDA 510(k)

OKI Surgical Planning Software

K-Number: K171617 · 2017-08-22

ApplicantOrtho Kinematics, Inc.
Decision Date2017-08-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OKI Surgical Planning Software is a medical device manufactured by Ortho Kinematics, Inc.. It received FDA 510(k) clearance on 2017-08-22 under approval number K171617. 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 OKI Surgical Planning Software?

OKI Surgical Planning Software is a medical device that received FDA 510(k) clearance on 2017-08-22. It is manufactured by Ortho Kinematics, Inc.. The 510(k) number is K171617.

When was OKI Surgical Planning Software approved by the FDA?

OKI Surgical Planning Software received FDA 510(k) clearance on 2017-08-22, under approval number K171617.

What company makes OKI Surgical Planning Software?

OKI Surgical Planning Software is manufactured by Ortho Kinematics, Inc..

What is the FDA product code for OKI Surgical Planning Software?

The FDA product code for OKI Surgical Planning Software is LLZ.

Related Clinical Trials

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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: 40856794 [Translational challenges and clinical potential of artificial intelligence in minimally invasive surgery]. Chirurgie (Heidelberg, Germany) (2025)

Other Devices by Ortho Kinematics, Inc.

K173247Surgical Planning Software version 1.1 K172327VMA™ System version 3.0

Related Devices (Code: LLZ)

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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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