510(k) Report

FDA applicant

Bespoke Technologies, LLC

Winston-Salemn, NC2 decisions2020–20220 recalls

FDA records 2 decisions for Bespoke Technologies, LLC (Winston-Salemn, NC) from 2020 to 2022: 2 510(k) clearances. Most are in product codes OVE (Intervertebral Fusion Device With Integrated…) and ODP (Intervertebral Fusion Device With Bone Graft…). Its devices cite 8 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Bespoke Technologies”.

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 Bespoke Technologies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2020: 12022: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

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

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Which product codes does it file in?

  • OVEIntervertebral Fusion Device With Integrated Fixation, Cervical1decision
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies · 20203cite it

What has FDA decided for it lately?

  • K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC · 2022
  • K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies · 2020

The one decision as Bespoke Technologies, LLC →The one decision as Bespoke Technologies →