FDA.reportPublic FDA data

Crescent™ Spinal System

Primary DI
00763000247379
Brand
Crescent™ Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
X1118066
Device description
INSERTER X1118066 40MM CRESCENT SHORTER
Published
2019-09-29
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
K052261000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052261000MODIFICATION TO: VERTE-STACK SPINAL SYSTEMMedtronic Sofamor Danek USA, Inc.2005-10-07MQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000247379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000247379007630002473797630002473790763000247379

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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
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
00199150071784Medtronic Reusable InstrumentsEX02260702026-05-24
00199150071791Medtronic Reusable InstrumentsEX02260802026-05-24
00199150071807Medtronic Reusable InstrumentsEX02260902026-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08033726407893DSCSINTEA PLUSTEK SRLMQP2015-10-09