# SpineFrontier, Inc. – FDA 483, Apr 2, 2026

Source: https://www.keypedia.com/records/483/spinefrontier-inc/84ca698e-fd95-48b5-97d3-f36e2c732333

> FDA 483 for SpineFrontier, Inc. on April 02, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SpineFrontier, Inc.
- Inspection Date: 2026-04-02
- Product Type: device
- Office Name: New England District Office
- Summary: An FDA inspection of SpineFrontier, Inc. dba LESpine Innovations in Burlington, MA, from March 30 to April 2, 2026, identified one observation. The firm failed to adequately maintain records of corrective actions, specifically regarding the documentation and cross-referencing of CAPA 404 with related complaints concerning issues with set screw locking during surgical procedures. This indicates a deficiency in their quality system for complaint handling and corrective actions.

## Related Documents

- [WARNING_LETTER - 2012-07-11](https://www.keypedia.com/records/warning_letter/spinefrontier-inc/9532f00d-fce5-44ed-9c32-15698e8e8b6d) — date: July 11, 2012

## Related Officers

- [Nabil Nakhoul](https://www.keypedia.com/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)

Company: https://www.keypedia.com/companies/spinefrontier-inc/2c027911-065a-410e-b340-9cd846d5d1a7

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144