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FDA 510(k)

Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL

K-Number: K230104 · 2023-10-16

ApplicantAnthogyr
Decision Date2023-10-16
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL is the device name listed in this FDA 510(k) record. The listed applicant is Anthogyr. It received FDA 510(k) clearance on 2023-10-16 under 510(k) number K230104. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL?

Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL is a medical device that received FDA 510(k) clearance on 2023-10-16. The listed applicant is Anthogyr. The 510(k) number is K230104.

When did Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL receive FDA 510(k) clearance?

Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL received FDA 510(k) clearance on 2023-10-16, under 510(k) number K230104.

Who is the listed applicant for Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL?

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

What is the FDA product code for Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL?

The FDA product code for Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL is DZE.

Related Clinical Trials

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.

NCT02482493All Polyethylene Versus Metal Backed Tibial Components in Knee ReplacementSUSPENDED

Other records listing Anthogyr 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.

K231072Anthogyr FlexiBase® titanium bases for Axiom® BLK233264Anthogyr INTEGRAL Guided Surgery CassettesK230680Anthogyr Surgical CassettesK160730Instrument kits

Related Devices (Code: DZE)

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.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.

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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