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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 the device name listed in this FDA 510(k) record. The listed applicant is Ortho Kinematics, Inc.. It received FDA 510(k) clearance on 2017-11-08 under 510(k) 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. The listed applicant is Ortho Kinematics, Inc.. The 510(k) number is K173247.

When did Surgical Planning Software version 1.1 receive FDA 510(k) clearance?

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

Who is the listed applicant for Surgical Planning Software version 1.1?

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 Surgical Planning Software version 1.1?

The FDA product code for Surgical Planning Software version 1.1 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.

K172327VMA™ System version 3.0K171617OKI Surgical Planning Software

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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