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FDA 510(k)

HIPGRAPHICS SYSTEM ONE W/ORTHOTOOL

K-Number: K894402 · 1989-11-17

ApplicantHipgraphics, Inc.
Decision Date1989-11-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HIPGRAPHICS SYSTEM ONE W/ORTHOTOOL is the device name listed in this FDA 510(k) record. The listed applicant is Hipgraphics, Inc.. It received FDA 510(k) clearance on 1989-11-17 under 510(k) number K894402. 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 HIPGRAPHICS SYSTEM ONE W/ORTHOTOOL?

HIPGRAPHICS SYSTEM ONE W/ORTHOTOOL is a medical device that received FDA 510(k) clearance on 1989-11-17. The listed applicant is Hipgraphics, Inc.. The 510(k) number is K894402.

When did HIPGRAPHICS SYSTEM ONE W/ORTHOTOOL receive FDA 510(k) clearance?

HIPGRAPHICS SYSTEM ONE W/ORTHOTOOL received FDA 510(k) clearance on 1989-11-17, under 510(k) number K894402.

Who is the listed applicant for HIPGRAPHICS SYSTEM ONE W/ORTHOTOOL?

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

What is the FDA product code for HIPGRAPHICS SYSTEM ONE W/ORTHOTOOL?

The FDA product code for HIPGRAPHICS SYSTEM ONE W/ORTHOTOOL is 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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