FDA applicant

Ortho Tec, LLC

California, CA22 decisions1999–20040 recalls

FDA records 22 decisions for Ortho Tec, LLC (California, CA) from 1999 to 2004: 22 510(k) clearances. Most are in product codes KWP (Appliance, Fixation, Spinal Interlaminal) and MNH (Orthosis, Spondylolisthesis Spinal Fixation). Its devices cite 3 predicates, 1 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 Ortho Tec, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ortho Tec, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ortho Tec, 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 “Ortho”

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

Ortho-Clinical Diagnostics, Inc. 152 Ortho Diagnostic Systems, Inc. 126 Ortho Development Corp. 64 Ortho Diagnostics, Inc. 24 Ortho Pharmaceutical Corp. 9 Ortho Source 9 Ortho Organizers, Inc. 8 Ortho Kinetics Corp. 7 Ortho Solutions Limited 6 Ortho Instruments 6 Ortho Kinematics, Inc. 6 Ortho Solutions UK, Ltd. 5

Ortho Tec, 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 “Ortho”