Actera hip system
K-Number: K221104 · 2022-08-04
ApplicantConformis, Inc.
Decision Date2022-08-04
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Actera hip system is a medical device manufactured by Conformis, Inc.. It received FDA 510(k) clearance on 2022-08-04 under approval number K221104. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Actera hip system?
Actera hip system is a medical device that received FDA 510(k) clearance on 2022-08-04. It is manufactured by Conformis, Inc.. The 510(k) number is K221104.
When was Actera hip system approved by the FDA?
Actera hip system received FDA 510(k) clearance on 2022-08-04, under approval number K221104.
What company makes Actera hip system?
Actera hip system is manufactured by Conformis, Inc..
What is the FDA product code for Actera hip system?
The FDA product code for Actera hip system is MEH.
Other Devices by Conformis, Inc.
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K153721iTotal Cruciate Retaining (CR) Knee Replacement System
K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System
K153217ConforMIS iTotal Posterior Stabilized Knee Replacement System
K170226iTotal Family Reusable Instrument Tray
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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.