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FDA 510(k)

ONE Planner Hip

K-Number: K210653 · 2021-07-07

ApplicantOrthosoft D/B/A Zimmer Cas
Decision Date2021-07-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ONE Planner Hip is the device name listed in this FDA 510(k) record. The listed applicant is Orthosoft D/B/A Zimmer Cas. It received FDA 510(k) clearance on 2021-07-07 under 510(k) number K210653. 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 ONE Planner Hip?

ONE Planner Hip is a medical device that received FDA 510(k) clearance on 2021-07-07. The listed applicant is Orthosoft D/B/A Zimmer Cas. The 510(k) number is K210653.

When did ONE Planner Hip receive FDA 510(k) clearance?

ONE Planner Hip received FDA 510(k) clearance on 2021-07-07, under 510(k) number K210653.

Who is the listed applicant for ONE Planner Hip?

The FDA 510(k) record lists Orthosoft D/B/A Zimmer Cas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONE Planner Hip?

The FDA product code for ONE Planner Hip is LLZ.

Other records listing Orthosoft D/B/A Zimmer Cas 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.

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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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