FDA 510(k)

PhantomMSK

K-Number: K182332 · 2019-02-15

Decision Date2019-02-15

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PhantomMSK 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 2019-02-15 under 510(k) number K182332. 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?

PhantomMSK is a medical device that received FDA 510(k) clearance on 2019-02-15. The listed applicant is OrthoGrid Systems, Inc.. The 510(k) number is K182332.

When did PhantomMSK receive FDA 510(k) clearance?

PhantomMSK received FDA 510(k) clearance on 2019-02-15, under 510(k) number K182332.

Who is the listed applicant for PhantomMSK?

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?

The FDA product code for PhantomMSK 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 K192279PhantomMSK Trauma

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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.