Surgalign Spine Technologies

FDA Regulatory Profile

Surgalign Spine Technologies appears in FDA public data with 0 recalls, 3 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent FDA inspection ended on Oct 25, 2018 (No Action Indicated (NAI)). Its most recent 510(k) clearance was granted on Aug 31, 2023.

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Summary

Total Recalls
0
510(k) Clearances
3
Inspections
3
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 25, 2018Deerfield, ILDevicesNo Action Indicated (NAI)3005725110
Dec 3, 2013Deerfield, ILDevicesNo Action Indicated (NAI)3005725110
Jan 5, 2010Deerfield, ILDevicesNo Action Indicated (NAI)3005725110

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).

Recent 510(k) Clearances

K-NumberDeviceDate
K231611HOLO Portal™ Surgical Guidance SystemAug 31, 2023
K221403Cortera Spinal Fixation SystemAug 19, 2022
K211254ARAI Surgical Navigation SystemJan 14, 2022