510(k) Report

FDA applicant

Intellirod Spine, Inc.

Akron, OH1 decision2019–20190 recalls

FDA records 1 decision for Intellirod Spine, Inc. (Akron, OH) in 2019: 1 De Novo grant. All are in product code QFP (Intraoperative Orthopedic Strain Sensor). 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 Intellirod Spine, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2019: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Intellirod Spine, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Intellirod Spine, Inc.’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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