FDA 510(k)

PhantomMSK Hip

K-Number: K210136 · 2021-02-18

Decision Date2021-02-18

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PhantomMSK Hip 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 2021-02-18 under 510(k) number K210136. 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 Hip?

PhantomMSK Hip is a medical device that received FDA 510(k) clearance on 2021-02-18. The listed applicant is OrthoGrid Systems, Inc.. The 510(k) number is K210136.

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

PhantomMSK Hip received FDA 510(k) clearance on 2021-02-18, under 510(k) number K210136.

Who is the listed applicant for PhantomMSK Hip?

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 Hip?

The FDA product code for PhantomMSK Hip 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 K192279PhantomMSK Trauma 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.