FDA 510(k)

Knee+

K-Number: K220104 · 2022-09-01

Decision Date2022-09-01

Product CodeSBF

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Knee+ is the device name listed in this FDA 510(k) record. The listed applicant is Pixee Medical. It received FDA 510(k) clearance on 2022-09-01 under 510(k) number K220104. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Knee+?

Knee+ is a medical device that received FDA 510(k) clearance on 2022-09-01. The listed applicant is Pixee Medical. The 510(k) number is K220104.

When did Knee+ receive FDA 510(k) clearance?

Knee+ received FDA 510(k) clearance on 2022-09-01, under 510(k) number K220104.

Who is the listed applicant for Knee+?

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

What is the FDA product code for Knee+?

The FDA product code for Knee+ is SBF.

Other records listing Pixee Medical 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.

K243975Knee+K233899Knee+K230789Knee+K213922FX SPS K202750Knee+

Related Devices (Code: SBF)

K261854xvision Spine systemAugmedics, Ltd.K253805Knee+Pixee Medical S.A.S.K252847NextAR Hip PlatformMedacta International S.A.K251639xvision Spine systemAugmedics, Ltd.K252054SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.K252530OptiVu™ ShoulderMr Surgical Solutions, LLC

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.