FDA applicant

Pinnacle Spine Group, LLC

Dallas, TX13 decisions2011–20170 recalls

FDA records 13 decisions for Pinnacle Spine Group, LLC (Dallas, TX) from 2011 to 2017: 13 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and FMF (Syringe, Piston). Its devices cite 37 predicates, 14 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Pinnacle Spine Group”.

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 Pinnacle Spine Group, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2011high 4 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Pinnacle Spine Group, LLC by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pinnacle Spine Group, 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 “Pinnacle”

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

Pinnacle Co., Ltd. 3 Pinnacle Biologics, Inc. 2 Pinnacle Distributors, Inc. 2 Pinnacle Products, Inc. 1 Pinnacle Intl., Inc. 1

Pinnacle Spine Group, 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 “Pinnacle”