FDA.reportPublic FDA data

MSB SOVEREIGN™ Spinal System

Primary DI
00643169511781
Brand
MSB SOVEREIGN™ Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
9010002035
Device description
SPACER 9010002035 SV L 42X30X16MM 24D CP
Published
2026-07-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172328000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172328000SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.2017-11-02OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169511781PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169511781006431695117816431695117810643169511781

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150041183N/A593250152026-07-17
00199150072323Medtronic Reusable InstrumentsX66309032026-07-19
00199150074525Medtronic Reusable InstrumentsEX01260082026-07-19
00199150076024Medtronic Reusable InstrumentsEX03260062026-07-17
00199150081875Medtronic Reusable InstrumentsX04260032026-07-19
00643169511651SOVEREIGN™ Spinal System90100020222026-07-19
00643169511675MSB SOVEREIGN™ Spinal System90100020232026-07-19
00643169511682MSB SOVEREIGN™ Spinal System90100020242026-07-19
00643169511705MSB SOVEREIGN™ Spinal System90100020302026-07-17
00643169511712MSB SOVEREIGN™ Spinal System90100020312026-07-19
00643169511729MSB SOVEREIGN™ Spinal System90100020322026-07-19
00643169511736MSB SOVEREIGN™ Spinal System90100020332026-07-19
00643169511774MSB SOVEREIGN™ Spinal System90100020342026-07-19
00643169511798MSB SOVEREIGN™ Spinal System90100020362026-07-19
00643169511804MSB SOVEREIGN™ Spinal System90100020372026-07-19
00643169511811MSB SOVEREIGN™ Spinal System90100020382026-07-19
00643169511828MSB SOVEREIGN™ Spinal System90100020392026-07-19
00643169511873MSB SOVEREIGN™ Spinal System90100020052026-07-19
00643169511880MSB SOVEREIGN™ Spinal System90100020062026-07-19
00643169511897MSB SOVEREIGN™ Spinal System90100020002026-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169511651SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511675MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511682MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511712MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511729MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511736MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511774MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511798MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511804MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511811MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511828MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511873MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511880MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511897MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511903MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511910MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511927MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511934MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511941MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511958MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511965MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169512016MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169512030MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169512047MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169512054SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169512061MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169512078MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169512085MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511705MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-17
00197157074050ZAVATION SCREWZavation LLCOVD2026-05-29