Axis Spine Technologies Ltd. – FDA Inspection, Aug 21, 2024

Record Details

This FDA Inspection record concerns Axis Spine Technologies Ltd., with an inspection on August 21, 2024, issued by the Center for Devices and Radiological Health, covering devices.

Company: Axis Spine Technologies Ltd.
Inspection Date: August 21, 2024
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: John A. Sciacchitano (Company Rep)

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ID · f99e3700-c927-4f83-9ea1-d7e2542cbe80

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1247165
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 803.50(a)(1)Report of Death or Serious Injury
21 CFR 820.198(a)Lack of or inadequate complaint procedures

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FDA Inspection

Axis Spine Technologies Ltd.August 21, 2024