FDA applicant

The Skeletal Design Partnership, Ltd.

Chesterland, OH1 decision2012–20120 recalls

FDA records 1 decision for The Skeletal Design Partnership, Ltd. (Chesterland, OH) in 2012: 1 510(k) clearance. All are in product code NKB (Thoracolumbosacral Pedicle Screw System). Its devices cite 9 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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 The Skeletal Design Partnership, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — The Skeletal Design Partnership, Ltd. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like The Skeletal Design Partnership, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “The”

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

Skeletal Dynamics, Inc. 40 Skeletal Kinetics, LLC 10

The Skeletal Design Partnership, Ltd.

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 “The”