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FDA 510(k)

RBknee

K-Number: K203696 · 2021-08-27

ApplicantRadiobotics Aps
Decision Date2021-08-27
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RBknee is the device name listed in this FDA 510(k) record. The listed applicant is Radiobotics Aps. It received FDA 510(k) clearance on 2021-08-27 under 510(k) number K203696. 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 RBknee?

RBknee is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is Radiobotics Aps. The 510(k) number is K203696.

When did RBknee receive FDA 510(k) clearance?

RBknee received FDA 510(k) clearance on 2021-08-27, under 510(k) number K203696.

Who is the listed applicant for RBknee?

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

What is the FDA product code for RBknee?

The FDA product code for RBknee is LLZ.

Related Devices (Code: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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