FDA applicant

Carbofix Orthpedics, Ltd.

Herzeliya, IL2 decisions2021–20230 recalls

FDA records 2 decisions for Carbofix Orthpedics, Ltd. (Herzeliya, IL) from 2021 to 2023: 2 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and ODP (Intervertebral Fusion Device With Bone Graft…). Its devices cite 11 predicates, 1 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 Carbofix Orthpedics, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Carbofix Orthpedics, Ltd. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Carbofix Orthpedics, Ltd.’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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Other applicant names beginning “Carbofix”

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

CarboFix Orthopedics, Ltd. 32 CarboFix Orhtopedics, Ltd. 1

Carbofix Orthpedics, Ltd.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Carbofix”