FDA.reportPublic FDA data

N/A

Primary DI
00885074000770
Brand
N/A
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
X1203056
Device description
CEMENT RESTRICTOR X1203056 TCR 11 X 25
Published
2015-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDKProsthesis, hip, cement restrictor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDKProsthesis, Hip, Cement RestrictorGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011443000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011443000THREADED CEMENT RESTRICTOR (CR) TITANIUMMedtronic Sofamor Danek USA, Inc.2001-08-03JDK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885074000770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885074000770008850740007708850740007700885074000770

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07630345710970MectaPlug PE IIMedacta International SAJDK2021-04-16
07630345710987MectaPlug PE IIMedacta International SAJDK2021-04-16
07630345710994MectaPlug PE IIMedacta International SAJDK2021-04-16
07630345711007MectaPlug PE IIMedacta International SAJDK2021-04-16
08053369431048Emotec srlEMOTEC SRLJDK2021-02-03
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00840019908771ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908788ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908795ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908801ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908818ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908825ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908832ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908849ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908856ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908863ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908870ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908887ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908894ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00840019908900ShurFit CRT Peek CagePRECISION SPINE, INC.JDK2019-04-12
00815362022122ShurFit ACIF Titanium PRECISION SPINE, INC.JDK2019-03-28
00840019929233ShurFit ACIF Titanium PRECISION SPINE, INC.JDK2019-03-28
00840019929257ShurFit ACIF Titanium PRECISION SPINE, INC.JDK2019-03-28
00840019929240ShurFit ACIF Titanium PRECISION SPINE, INC.JDK2019-03-27
00840019929264ShurFit ACIF Titanium PRECISION SPINE, INC.JDK2019-03-27
00840019929271ShurFit ACIF Titanium PRECISION SPINE, INC.JDK2019-03-27
08031497001401Cement RestrictorTECRES SPAJDK2015-10-12