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Medtronic Sofamor Danek USA Inc, Memphis, TN – FDA Inspections

Inspection records and compliance data for Medtronic Sofamor Danek USA Inc in Memphis, Tennessee. 13 FDA inspections on record, 1 Form 483, last inspected February 06, 2026.

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Company Profile

This profile covers Medtronic Sofamor Danek USA Inc based in Memphis, Tennessee, United States.

FDA Inspection History

FDA inspections
13
OAI
0
VAI
4
NAI
8
Unclassified
1
Form 483s
1
Warning letters
0

First inspected October 10, 2008. Last inspected February 6, 2026.

FDA inspections (13)

DateResultFDA center(s)Insp. #
February 6, 2026NAIMedical Devices & Rad Health · Bioresearch Monitoring1302636
May 3, 2017Not classifiedMedical Devices & Rad Health1029473
November 3, 2015VAIMedical Devices & Rad Health · Bioresearch Monitoring950920
October 23, 2015NAIMedical Devices & Rad Health · Postmarket Assurance: Devices946127
March 11, 2014VAIMedical Devices & Rad Health · Compliance: Devices869386
July 15, 2013NAIMedical Devices & Rad Health · Bioresearch Monitoring845563
June 6, 2012NAIMedical Devices & Rad Health · Postmarket Assurance: Devices790663
August 6, 2010VAIMedical Devices & Rad Health · Bioresearch Monitoring677188
March 4, 2010VAIMedical Devices & Rad Health · Bioresearch Monitoring651661
February 25, 2010NAIMedical Devices & Rad Health · Postmarket Assurance: Devices649964
October 6, 2009NAIMedical Devices & Rad Health · Compliance: Devices621844
December 31, 2008NAIMedical Devices & Rad Health · Compliance: Devices554065
October 10, 2008NAIMedical Devices & Rad Health · Bioresearch Monitoring545781
FDA documents

No Form 483s, Warning Letters or EIRs on record.

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DeRoyal Industries Inc., dba Hospital Disposables
Company Information

Name

Medtronic Sofamor Danek USA Inc

FEI Number

1000477302

Address

1800 Pyramid Pl, Memphis, Tennessee 38132, United States

Country

United States

ID: 335e1ae6-cdf4-4132-81da-e8914c45ec7c

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