FDA Inspection
SpineFrontier, Inc.SpineFrontier, Inc. – FDA Inspection, Apr 2, 2026
Record Details
This FDA Inspection record concerns SpineFrontier, Inc., with an inspection on April 2, 2026, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 223a3b2c-91f8-4703-ab5e-79b562342835
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1311082
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- ISO 13485:2016 Clause 7.5.8Corrective action records not maintained
- ISO 13485:2016 Clause 8.5.2Corrective action records not maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of SpineFrontier, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 29, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 29, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 10, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 5, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 11, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for SpineFrontier, Inc.
- FDA Inspection 1078558 - 2019-01-29
- FDA Inspection 1036897 - 2017-11-29
- FDA Inspection 960829 - 2016-02-10
- FDA Inspection 844341 - 2013-08-05
- FDA Inspection 791636 - 2012-07-11
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