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 a medical device manufactured by Orthosoft Inc (D/B/A Zimmer Cas). It received FDA 510(k) clearance on 2023-05-23 under approval 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. It is manufactured by Orthosoft Inc (D/B/A Zimmer Cas). The 510(k) number is K231162.
When was ROSA Hip System approved by the FDA?
ROSA Hip System received FDA 510(k) clearance on 2023-05-23, under approval number K231162.
What company makes ROSA Hip System?
ROSA Hip System is manufactured by Orthosoft Inc (D/B/A Zimmer Cas).
What is the FDA product code for ROSA Hip System?
The FDA product code for ROSA Hip System is LLZ.
Other Devices by Orthosoft Inc (D/B/A Zimmer Cas)
Related Devices (Code: LLZ)
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.