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FDA 510(k)

ROSA Hip System

K-Number: K231162 · 2023-05-23

ApplicantOrthosoft Inc (D/B/A Zimmer Cas)
Decision Date2023-05-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ROSA Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Orthosoft Inc (D/B/A Zimmer Cas). It received FDA 510(k) clearance on 2023-05-23 under 510(k) number K231162. 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 ROSA Hip System?

ROSA Hip System is a medical device that received FDA 510(k) clearance on 2023-05-23. The listed applicant is Orthosoft Inc (D/B/A Zimmer Cas). The 510(k) number is K231162.

When did ROSA Hip System receive FDA 510(k) clearance?

ROSA Hip System received FDA 510(k) clearance on 2023-05-23, under 510(k) number K231162.

Who is the listed applicant for ROSA Hip System?

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

What is the FDA product code for ROSA Hip System?

The FDA product code for ROSA Hip System is LLZ.

Other records listing Orthosoft Inc (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.

K261510Signature™ ONE SystemK260582ROSA® Shoulder SystemK260104Signature™ ONE SystemK251314Rosa® Knee SystemK242864ROSA® Knee SystemK233199ROSA® Shoulder System

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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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