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FDA 510(k)

ACTERA™ hip system

K-Number: K231178 · 2023-05-23

ApplicantConformis, Inc.
Decision Date2023-05-23
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 2023-05-23 under 510(k) number K231178. 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 2023-05-23. The listed applicant is Conformis, Inc.. The 510(k) number is K231178.

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

ACTERA™ hip system received FDA 510(k) clearance on 2023-05-23, under 510(k) number K231178.

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.

K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) InsertsK223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement SystemK230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemK231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSK230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) InsertK221104Actera™ hip system

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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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