FDA.reportPublic FDA data

Sovereign™ Spinal System

Primary DI
00643169636873
Brand
Sovereign™ Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
79615212
Device description
TRIAL 79615212 M 12MM 12 DEG ALIF/OLIF
Published
2017-02-16
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
K162680000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162680000SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.2016-12-14OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169636873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169636873006431696368736431696368730643169636873

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle12degree
Depth27Millimeter
Height12Millimeter
Width37Millimeter

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
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169328716N/A30029332017-12-09
00763000891503CD HORIZON Spinal System559006195502026-09-28
00763000891527CD HORIZON Spinal System559006101502026-09-28
00763000891541CD HORIZON Spinal System559016101502026-09-28
00763000891558CD HORIZON Spinal System559016101602026-09-28
00763000891572CD HORIZON Spinal System559016175502026-09-28
00763000891589CD HORIZON Spinal System559016175602026-09-28
00763000891602CD HORIZON Spinal System559016185502026-09-28
00763000891619CD HORIZON Spinal System559016185602026-09-28
00763000891626CD HORIZON Spinal System559016195502026-09-28
00763000891633CD HORIZON Spinal System559016195602026-09-28
00763000992521INFINITY OCT SystemG36535102026-09-26
00763000992552INFINITY OCT SystemG36535162026-09-26
00643169016798Medtronic Reusable InstrumentsX06110012022-11-27
00643169016804Medtronic Reusable InstrumentsX06110022022-11-27
00673978816241Medtronic Reusable InstrumentsX06990402022-11-27
00613994423559N/AX07072142022-11-14
00613994423566N/AX07072152022-11-14
00613994423573N/AX07072162022-11-14
00613994423603N/AX07072192022-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916184SABER-XA, Expandable Spacer, 37x28mm,13mm, (12°)ELEVATION SPINE, INC.OVD2026-10-01
10888857160460CASCADIA™ Interbody SystemVB Spine LLCOVD2018-04-16
10888857223769CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223776CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223783CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223790CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223868CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223875CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223882CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223899CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223967CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223974CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223981CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857223998CASCADIA™ Interbody SystemVB Spine LLCOVD2018-02-08
10888857217355CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217577CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217584CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217591CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19
10888857217669CASCADIA™ Interbody SystemVB Spine LLCOVD2017-07-19