FDA applicant

Foundry Newcoxi, Inc.

Los Gatos, CA1 decision2012–20120 recalls

FDA records 1 decision for Foundry Newcoxi, Inc. (Los Gatos, CA) in 2012: 1 510(k) clearance. All are in product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). 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 Foundry Newcoxi, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

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

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Other applicant names beginning “Foundry”

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

Foundry Newco X, Inc. 1

Foundry Newcoxi, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Foundry”