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FDA 510(k)

CORE Shoulder System

K-Number: K241470 · 2025-02-20

ApplicantLinkBio Corp.
Decision Date2025-02-20
Product CodeQHE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CORE Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is LinkBio Corp.. It received FDA 510(k) clearance on 2025-02-20 under 510(k) number K241470. 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 CORE Shoulder System?

CORE Shoulder System is a medical device that received FDA 510(k) clearance on 2025-02-20. The listed applicant is LinkBio Corp.. The 510(k) number is K241470.

When did CORE Shoulder System receive FDA 510(k) clearance?

CORE Shoulder System received FDA 510(k) clearance on 2025-02-20, under 510(k) number K241470.

Who is the listed applicant for CORE Shoulder System?

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

What is the FDA product code for CORE Shoulder System?

The FDA product code for CORE Shoulder System is QHE.

Other records listing LinkBio Corp. 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.

K190181Instruments for LINK MEGASYSTEM-C Family

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-SideK243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, 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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