FDA.reportPublic FDA data

VERTE-STACK® Spinal System

Primary DI
00613994619167
Brand
VERTE-STACK® Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
X1208072
Device description
TRIAL X1208072 MEDIUM 8MM
Published
2015-09-01
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
MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043566000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043566000MODIFICATION TO VERTE-STACK SPINAL SYSTEMMedtronic Sofamor Danek2005-01-07MQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994619167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994619167006139946191676139946191670613994619167

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

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
00840283403460LumiVy™VY SPINE LLCMQP2026-06-05
00763000857844T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-01
00763000857943T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-01
00763000857998T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-01
07640172551103KONG-TL VBR System, Expansion Handleicotec AGMQP2020-06-19
07640172551110KONG-TL VBR System, Locking Rodicotec AGMQP2020-06-19
08033726407923DSCSINTEA PLUSTEK SRLMQP2015-10-16
08033726404250DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726404267DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407664DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407671DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407701DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407718DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407725DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407732DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407749DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407756DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407763DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407770DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407787DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407794DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407800DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407817DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407824DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407831DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407848DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407855DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407862DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407879DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407886DSCSINTEA PLUSTEK SRLMQP2015-10-09