EARP Interbody System
K-Number: K242457 · 2024-10-07
ApplicantRetropsoas Technologies, LLC
Decision Date2024-10-07
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
EARP Interbody System is a medical device manufactured by Retropsoas Technologies, LLC. It received FDA 510(k) clearance on 2024-10-07 under approval number K242457. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EARP Interbody System?
EARP Interbody System is a medical device that received FDA 510(k) clearance on 2024-10-07. It is manufactured by Retropsoas Technologies, LLC. The 510(k) number is K242457.
When was EARP Interbody System approved by the FDA?
EARP Interbody System received FDA 510(k) clearance on 2024-10-07, under approval number K242457.
What company makes EARP Interbody System?
EARP Interbody System is manufactured by Retropsoas Technologies, LLC.
What is the FDA product code for EARP Interbody System?
The FDA product code for EARP Interbody System is MAX.
Related Clinical Trials
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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.