What did the FDA find wrong with Spinal Elements, Inc?

The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.

Are Spinal Elements, Inc products safe to use?

Based on the FDA's findings, consumers should exercise caution. The company was found to have regulatory issues that may affect product safety.

What should I do if I've used Spinal Elements, Inc products?

If you have used products from Spinal Elements, Inc and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.

Spinal Elements, Inc FDA Warning (2017)

Name: Spinal Elements, Inc FDA Warning (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:23.201371

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on November 01, 2017

MODERATE SEVERITY 2017

Disclaimer: This report is an analysis of a public FDA warning letter. It is not medical advice. If you have consumed these products and feel unwell, contact a healthcare professional immediately.

Executive Summary

The FDA issued a warning letter to Spinal Elements, Inc on November 01, 2017 citing regulatory violations. The letter was issued by the FDA.

Regulatory Violations

Detailed Analysis

False Claims and Regulatory Violations

The FDA identified regulatory violations in Spinal Elements, Inc's operations or product claims.

Potential Health Risks

Office of Medical Devices and Radiological Health OperationsDivision 3 West19701 FairchildIrvine, CA 92612

Regulatory Context

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 21-14 dated June 12, 2014. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Kelly D. SheppardDirector, Compliance Branch

Key Entities Identified

Spinal Elements Inc FDA Warning Letter

Frequently Asked Questions

What did the FDA find wrong with Spinal Elements, Inc?: The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
Are Spinal Elements, Inc products safe to use?: Based on the FDA's findings, consumers should exercise caution. The company was found to have regulatory issues that may affect product safety.
What should I do if I've used Spinal Elements, Inc products?: If you have used products from Spinal Elements, Inc and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.

Source Document

This report is based on an official FDA warning letter. The original document is a public record.

View Original FDA Warning Letter

Medical Disclaimer: This report is an analysis of public FDA warning letters. It is not medical advice. If you have consumed these products and feel unwell, contact a healthcare professional immediately. You can report adverse events to the FDA MedWatch program.