FDA.reportPublic FDA data

SOVEREIGN™ Spinal System

Primary DI
00613994545305
Brand
SOVEREIGN™ Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
7967079
Device description
SHAFT 7967079 S INSERTER
Published
2015-07-02
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
MAXIntervertebral fusion device with bone graft, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994545305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994545305006139945453056139945453050613994545305

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
00199150076161Medtronic Reusable InstrumentsX02260412026-06-05
00199150076178Medtronic Reusable InstrumentsX02260422026-06-05
00199150080304Medtronic Reusable InstrumentsX08032922026-06-05
00199150077359Medtronic Reusable InstrumentsEX02260492026-06-01
00199150077366Medtronic Reusable InstrumentsEX02260512026-06-01
00763000857844T2 STRATOSPHERE™ Expandable Corpectomy System43612552026-06-01
00763000857943T2 STRATOSPHERE™ Expandable Corpectomy System43612202026-06-01
00763000857998T2 STRATOSPHERE™ Expandable Corpectomy System43613082026-06-01
00763000881252Clydesdale™ Spinal System49860402026-05-29
00199150073504Medtronic Reusable InstrumentsEX12250012026-05-25
00199150071685Medtronic Reusable InstrumentsEX02261402026-05-24
00199150071692Medtronic Reusable InstrumentsEX02261502026-05-24
00199150071708Medtronic Reusable InstrumentsEX02261602026-05-24
00199150071715Medtronic Reusable InstrumentsEX02261702026-05-24
00199150071722Medtronic Reusable InstrumentsEX02261802026-05-24
00199150071739Medtronic Reusable InstrumentsEX02261902026-05-24
00199150071746Medtronic Reusable InstrumentsEX02262002026-05-24
00199150071753Medtronic Reusable InstrumentsEX02260402026-05-24
00199150071760Medtronic Reusable InstrumentsEX02260502026-05-24
00199150071777Medtronic Reusable InstrumentsEX02260602026-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800043912870N/ATDM Co., Ltd.MAX2026-06-02
08800043912887N/ATDM Co., Ltd.MAX2026-06-02
08800043912894N/ATDM Co., Ltd.MAX2026-06-02
08800043912900N/ATDM Co., Ltd.MAX2026-06-02
08800043912917N/ATDM Co., Ltd.MAX2026-06-02
08800043912924N/ATDM Co., Ltd.MAX2026-06-02
08800043912931N/ATDM Co., Ltd.MAX2026-06-02
08800043912948N/ATDM Co., Ltd.MAX2026-06-02
08800043912955N/ATDM Co., Ltd.MAX2026-06-02
08800043912962N/ATDM Co., Ltd.MAX2026-06-02
08800043912979N/ATDM Co., Ltd.MAX2026-06-02
08800043912986N/ATDM Co., Ltd.MAX2026-06-02
08800043912993N/ATDM Co., Ltd.MAX2026-06-02
08800043913006N/ATDM Co., Ltd.MAX2026-06-02
08800043913013N/ATDM Co., Ltd.MAX2026-06-02
08800043913020N/ATDM Co., Ltd.MAX2026-06-02
08800043913037N/ATDM Co., Ltd.MAX2026-06-02
08800043913044N/ATDM Co., Ltd.MAX2026-06-02
08800043913051N/ATDM Co., Ltd.MAX2026-06-02
08800043913068N/ATDM Co., Ltd.MAX2026-06-02
08800043913075N/ATDM Co., Ltd.MAX2026-06-02
08800043964183N/ATDM Co., Ltd.MAX2026-06-02
08800043964190N/ATDM Co., Ltd.MAX2026-06-02
08800043964206N/ATDM Co., Ltd.MAX2026-06-02
08800043964213N/ATDM Co., Ltd.MAX2026-06-02
08800043964220N/ATDM Co., Ltd.MAX2026-06-02
08800043964237N/ATDM Co., Ltd.MAX2026-06-02
08800043964244N/ATDM Co., Ltd.MAX2026-06-02
08800043964251N/ATDM Co., Ltd.MAX2026-06-02
08800043964268N/ATDM Co., Ltd.MAX2026-06-02