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FDA 510(k)

THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE

K-Number: K112109 · 2011-12-22

ApplicantOrtho Kinematics, Inc.
Decision Date2011-12-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE 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 2011-12-22 under 510(k) number K112109. 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 THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE?

THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE is a medical device that received FDA 510(k) clearance on 2011-12-22. The listed applicant is Ortho Kinematics, Inc.. The 510(k) number is K112109.

When did THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE receive FDA 510(k) clearance?

THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE received FDA 510(k) clearance on 2011-12-22, under 510(k) number K112109.

Who is the listed applicant for THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE?

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 THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE?

The FDA product code for THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE is LLZ.

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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 3.0K171617OKI Surgical Planning SoftwareK130743THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL

Related Devices (Code: LLZ)

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.

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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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