CORE Shoulder System— 510(k) K241470

Substantially Equivalent

LinkBio Corp.

FDA 510(k) clearance K241470 for CORE Shoulder System, Substantially Equivalent on 2025-02-20. Applicant: LinkBio Corp.. Device class: 2.

Clearance details

Applicant: LinkBio Corp.
Product code: Code QHE
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2024-05-24
Decision date: 2025-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dover, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QHE

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K251558 — Precision AI Surgical Planning System (PAI-SPS)2026-01-12
K243509 — Archer PSI System2025-05-12

More clearances from LinkBio Corp.

K190181 — Instruments for LINK MEGASYSTEM-C Family2019-10-25

Recalls naming K241470

K-number listed on FDA's recall record

Z-1810-2026 — LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.Class II·Ongoing·Linkbio Corp.·20260312

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K241470.

Data sourced from openFDA. This site is unofficial and independent of the FDA.