FDA applicant

Core Essence Orthopaedics, LLC

Yardley, PA6 decisions2007–20110 recalls

FDA records 6 decisions for Core Essence Orthopaedics, LLC (Yardley, PA) from 2007 to 2011: 6 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and JDR (Staple, Fixation, Bone). Its devices cite 26 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Core Essence Orthopaedics, Inc.”, “Core Essence Orthopaedics”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Core Essence Orthopaedics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007high 2 (2007) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Core Essence Orthopaedics, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Core Essence Orthopaedics, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Core”

FDA records each applicant name separately; these may or may not be the same firm.

Core-Vent Corp. 25 Core Dynamics, Inc. 23 Core-M, Inc. 4 Core Medical, Inc. 3 Core-Nexus 2 Core-Vent Bio-Engineering, Inc. 1 Core 3D Protech, S.L. 1 Core Healthcare, Ltd. 1 Core Access Surgical Technologies, Inc. 1 Core Scientific, Ltd. 1 Core Scientific Creation, Ltd. 1

Core Essence Orthopaedics, LLC

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Core”