FDA 510(k)

PhantomMSK Trauma

K-Number: K192279 · 2019-12-07

Decision Date2019-12-07

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PhantomMSK Trauma is the device name listed in this FDA 510(k) record. The listed applicant is OrthoGrid Systems, Inc.. It received FDA 510(k) clearance on 2019-12-07 under 510(k) number K192279. 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 PhantomMSK Trauma?

PhantomMSK Trauma is a medical device that received FDA 510(k) clearance on 2019-12-07. The listed applicant is OrthoGrid Systems, Inc.. The 510(k) number is K192279.

When did PhantomMSK Trauma receive FDA 510(k) clearance?

PhantomMSK Trauma received FDA 510(k) clearance on 2019-12-07, under 510(k) number K192279.

Who is the listed applicant for PhantomMSK Trauma?

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

What is the FDA product code for PhantomMSK Trauma?

The FDA product code for PhantomMSK Trauma is LLZ.

Other records listing OrthoGrid Systems, 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.

K260077OrthoGrid Hip AI® 4.0 K210136PhantomMSK Hip K182332PhantomMSK

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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.