510(k) Report

FDA applicant

Orthotec, Inc.

Pleasant Hill, CA1 decision1998–19980 recalls

FDA records 1 decision for Orthotec, Inc. (Pleasant Hill, CA) in 1998: 1 510(k) clearance. All are in product code KWP (Appliance, Fixation, Spinal Interlaminal). Its devices cite 3 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 Orthotec, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Orthotec, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Orthotec, 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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Which product codes does it file in?

  • KWPAppliance, Fixation, Spinal Interlaminal1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K983353SCS Spinal SystemOrthotec, Inc. · 19982cite it

What has FDA decided for it lately?

  • K983353SCS Spinal SystemOrthotec, Inc. · 1998

The one decision as Orthotec, Inc. →