FDA.reportPublic FDA data

SOVEREIGN™ Spinal System

Primary DI
00643169645998
Brand
SOVEREIGN™ Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
7969000
Device description
TRAY 7969000 SOVREIGN 18/24/30 DEG TRIAL
Published
2018-03-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00643169645998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169645998006431696459986431696459980643169645998

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height2.23Inch
Length20.98Inch
Width10.09Inch

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169839397INFINITY™ Occipitocervical Upper Thoracic System36070052018-06-10
00199150082780Medtronic Reusable InstrumentsX02260232026-07-04
00199150082797Medtronic Reusable InstrumentsX02260242026-07-04
00199150082803Medtronic Reusable InstrumentsX02260252026-07-04
00199150082810Medtronic Reusable InstrumentsX02260262026-07-04
00199150082827Medtronic Reusable InstrumentsX02260272026-07-04
00199150082834Medtronic Reusable InstrumentsX02260282026-07-04
00199150082841Medtronic Reusable InstrumentsX02260292026-07-04
00199150082858Medtronic Reusable InstrumentsX02260302026-07-04
00199150082865Medtronic Reusable InstrumentsX02260312026-07-04
00199150082872Medtronic Reusable InstrumentsX02260322026-07-04
00199150082889Medtronic Reusable InstrumentsX02260332026-07-04
00199150082896Medtronic Reusable InstrumentsX02260342026-07-04
00763000873714MSB SHILLA Growth Guidance System76750252026-07-04
00763000875176MSB SHILLA Growth Guidance System76755352026-07-04
00643169101296MSB VERTEX® Reconstruction SystemG77538052026-06-27
00643169465879MSB CD HORIZON Spinal SystemX10131802026-06-28
00763000857820T2 STRATOSPHERE™ Expandable Corpectomy System43612052026-06-26
00763000858001T2 STRATOSPHERE™ Expandable Corpectomy System4361203002026-06-26
00643169190542CLYDESDALE PTC™ Spinal System49868402016-04-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197157074166ZAVATION SCREWZavation LLCOVD2026-05-29
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00197157074197ZAVATION SCREWZavation LLCOVD2026-05-29
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00197157074210ZAVATION SCREWZavation LLCOVD2026-05-29
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00197157074265ZAVATION SCREWZavation LLCOVD2026-05-29
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00197157074289ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074296ZAVATION SCREWZavation LLCOVD2026-05-29
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00197157074326ZAVATION SCREWZavation LLCOVD2026-05-29
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00197157074340ZAVATION SCREWZavation LLCOVD2026-05-29