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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Conformis, Inc.. It received FDA 510(k) clearance on 2022-08-04 under 510(k) 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. The listed applicant is Conformis, Inc.. The 510(k) number is K221104.

When did Actera™ hip system receive FDA 510(k) clearance?

Actera™ hip system received FDA 510(k) clearance on 2022-08-04, under 510(k) number K221104.

Who is the listed applicant for Actera™ hip system?

The FDA 510(k) record lists Conformis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Actera™ hip system?

The FDA product code for Actera™ hip system is MEH.

Other records listing Conformis, Inc. 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: MEH)

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.

K261576Icona Hip StemCorin, Ltd.K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KGK251166Mfinity Femoral SystemMedacta International S.A.K251052Trivicta® Hip StemOrtho Development Corp.K242315Resolve Modular Revision Hip StemUnited Orthopedic CorporationK243839Alteon® HA Femoral StemsExactech, 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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