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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 the device name listed in this FDA 510(k) record. The listed applicant is Ortho Kinematics, Inc.. It received FDA 510(k) clearance on 2017-08-22 under 510(k) 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. The listed applicant is Ortho Kinematics, Inc.. The 510(k) number is K171617.

When did OKI Surgical Planning Software receive FDA 510(k) clearance?

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

Who is the listed applicant for OKI Surgical Planning Software?

The FDA 510(k) record lists Ortho Kinematics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Ortho Kinematics, 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.

K173247Surgical Planning Software version 1.1K172327VMA™ System version 3.0

Related Devices (Code: LLZ)

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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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