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FDA 510(k)

Arthrex Virtual Implant Positioning (VIP) System Software

K-Number: K241097 · 2024-10-02

ApplicantArthrex, Inc.
Decision Date2024-10-02
Product CodeQHE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Virtual Implant Positioning (VIP) System Software is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2024-10-02 under 510(k) number K241097. The device is classified under product code QHE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex Virtual Implant Positioning (VIP) System Software?

Arthrex Virtual Implant Positioning (VIP) System Software is a medical device that received FDA 510(k) clearance on 2024-10-02. The listed applicant is Arthrex, Inc.. The 510(k) number is K241097.

When did Arthrex Virtual Implant Positioning (VIP) System Software receive FDA 510(k) clearance?

Arthrex Virtual Implant Positioning (VIP) System Software received FDA 510(k) clearance on 2024-10-02, under 510(k) number K241097.

Who is the listed applicant for Arthrex Virtual Implant Positioning (VIP) System Software?

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

What is the FDA product code for Arthrex Virtual Implant Positioning (VIP) System Software?

The FDA product code for Arthrex Virtual Implant Positioning (VIP) System Software is QHE.

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.

NCT07690995Evaluating a New Software (OTOGUIDE) to Help Monitor Electrode Insertion During Cochlear Implant Surgery.NOT_YET_RECRUITINGNCT07727980Tissue Preservation in Immediate 1C Implants Using an Anatomical Prefabricated Healing AbutmentNOT_YET_RECRUITING

Other records listing Arthrex, 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.

K262357Arthrex Bioabsorbable PushLock Suture AnchorsK260624Arthrex Radial Head Replacement SystemK260018Arthrex FiberButtonK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemK253931Arthrex Bioabsorbable PushLock Suture AnchorsK254215Arthrex Beaming System

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Related Devices (Code: QHE)

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.

K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerMaterialise NVK261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CASK260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CASK251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.K243509Archer PSI System3D-SideK241470CORE Shoulder SystemLinkBio Corp.

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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