FDA Inspection 1271403 — Atlas Spine, Inc.

Atlas Spine, Inc. — FEI 3003855635

The FDA completed an inspection of Atlas Spine, Inc. on May 27, 2025 in Jupiter, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 27, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Compliance: Devices
Location
Jupiter, FL (United States)

Citations

IDCFRDescription
337221 CFR 820.198(d)Records of MDR Investigation