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FDA 510(k)

ORTHOPLAN

K-Number: K974406 · 1998-02-18

ApplicantOrtho-Graphics, Inc.
Decision Date1998-02-18
Product CodeHWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOPLAN is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Graphics, Inc.. It received FDA 510(k) clearance on 1998-02-18 under 510(k) number K974406. The device is classified under product code HWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOPLAN?

ORTHOPLAN is a medical device that received FDA 510(k) clearance on 1998-02-18. The listed applicant is Ortho-Graphics, Inc.. The 510(k) number is K974406.

When did ORTHOPLAN receive FDA 510(k) clearance?

ORTHOPLAN received FDA 510(k) clearance on 1998-02-18, under 510(k) number K974406.

Who is the listed applicant for ORTHOPLAN?

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

What is the FDA product code for ORTHOPLAN?

The FDA product code for ORTHOPLAN is HWT.

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Related Devices (Code: HWT)

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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