Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3006404071.
Observations2
Issue DateFebruary 13, 2026
StatusNo Warning Letter
Establishment TypeManufacturer
Related Inspections9
Establishment Details
Firm
SpineSmith Holdings, LLC
Location
Austin, Texas
FEI Number
3006404071
Establishment Type
Manufacturer
Product Type
Devices
Issue Date
February 13, 2026
Country
United States
Inspection History, 2008 to 2026
NAI3
VAI5
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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