FDA applicant

Sintea Plustek, LLC

Fr. Myers, FL4 decisions2012–20140 recalls

FDA records 4 decisions for Sintea Plustek, LLC (Fr. Myers, FL) from 2012 to 2014: 4 510(k) clearances. Most are in product codes NDN (Cement, Bone, Vertebroplasty) and MNH (Orthosis, Spondylolisthesis Spinal Fixation). Its devices cite 10 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Sintea Plustek”.

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 Sintea Plustek, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2012high 2 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Sintea Plustek, LLC by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sintea Plustek, LLC’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 “Sintea”

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

Sintea Biotech, Inc. 10 Sintea Plastek, LLC 2

Sintea Plustek, LLC

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Sintea”