FDA applicant

Radicle Orthopaedics, Inc.

New York, NY1 decision2017–20170 recalls

FDA records 1 decision for Radicle Orthopaedics, Inc. (New York, NY) in 2017: 1 510(k) clearance. All are in product code HWC (Screw, Fixation, Bone). 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 Radicle Orthopaedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Radicle Orthopaedics, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Radicle Orthopaedics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?