FDA applicant

Sintea Biotech, Inc.

Miami Beach, FL10 decisions2002–20090 recalls

FDA records 10 decisions for Sintea Biotech, Inc. (Miami Beach, FL) from 2002 to 2009: 10 510(k) clearances. Most are in product codes JEC (Component, Traction, Invasive) and KWP (Appliance, Fixation, Spinal Interlaminal). Its devices cite 13 predicates, 3 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 Sintea Biotech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007high 2 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sintea Biotech, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sintea Biotech, Inc.’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 Plustek, LLC 4 Sintea Plastek, LLC 2

Sintea Biotech, Inc.

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 “Sintea”