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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 a medical device manufactured by LinkBio Corp.. It received FDA 510(k) clearance on 2025-02-20 under approval 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. It is manufactured by LinkBio Corp.. The 510(k) number is K241470.

When was CORE Shoulder System approved by the FDA?

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

What company makes CORE Shoulder System?

CORE Shoulder System is manufactured by LinkBio Corp..

What is the FDA product code for CORE Shoulder System?

The FDA product code for CORE Shoulder System is QHE.

Related Clinical Trials

NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT05951491 Improving Arm Function Using Wearable Exoskeletons SUSPENDED NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT01480440 Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System ACTIVE_NOT_RECRUITING NCT07550543 PEMF Therapy in Shoulder Tendinopathy RECRUITING NCT07421245 OsseoFit Stemless Shoulder System (Anatomic) NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

Other Devices by LinkBio Corp.

K190181Instruments for LINK MEGASYSTEM-C Family

Related Devices (Code: QHE)

K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) K202454Smart SPACE Shoulder SystemTechmah Medical, LLC K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) K193560Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase PlannerMaterialise NV K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) K202151Smart SPACE Shoulder SystemTechmah Medical, LLC

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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