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FDA 510(k)

Surgical Planning Software version 1.1

K-Number: K173247 · 2017-11-08

ApplicantOrtho Kinematics, Inc.
Decision Date2017-11-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Surgical Planning Software version 1.1 is a medical device manufactured by Ortho Kinematics, Inc.. It received FDA 510(k) clearance on 2017-11-08 under approval number K173247. 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 Surgical Planning Software version 1.1?

Surgical Planning Software version 1.1 is a medical device that received FDA 510(k) clearance on 2017-11-08. It is manufactured by Ortho Kinematics, Inc.. The 510(k) number is K173247.

When was Surgical Planning Software version 1.1 approved by the FDA?

Surgical Planning Software version 1.1 received FDA 510(k) clearance on 2017-11-08, under approval number K173247.

What company makes Surgical Planning Software version 1.1?

Surgical Planning Software version 1.1 is manufactured by Ortho Kinematics, Inc..

What is the FDA product code for Surgical Planning Software version 1.1?

The FDA product code for Surgical Planning Software version 1.1 is LLZ.

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Related PubMed Literature

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Other Devices by Ortho Kinematics, Inc.

K172327VMA™ System version 3.0 K171617OKI Surgical Planning Software

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Official Source

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