FDA applicant

Orion Biotech, Inc.

Taipei, TW1 decision2020–20200 recalls

FDA records 1 decision for Orion Biotech, Inc. (Taipei, TW) in 2020: 1 510(k) clearance. All are in product code NKB (Thoracolumbosacral Pedicle Screw System). Its devices cite 1 predicate, 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 Orion Biotech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Orion Biotech, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Orion”

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

Orion Life Systems, Inc. 33 Orion Diagnostica, Inc. 32 Orion Corp. 21 Orion Diagnostica, Div. Orion Corp. 4 Orion Corporation Soredex 4 Orion Industries 1

Orion Biotech, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Orion”