FDA.reportPublic FDA data

N/A

Primary DI
00721902872693
Brand
N/A
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
X0703019
Device description
CEMENT RESTRICTOR X0703019 8X22X12 PEEK
Published
2015-07-31
Public version status
Update
Distribution status
Not 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
K010528000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010528000TITANIUM CEMENT RESTRICTOR MATERIAL PEEKMedtronic Sofamor Danek USA, Inc.2001-10-10JDK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00721902872693PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00721902872693007219028726937219028726930721902872693

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
Height12Millimeter
Length22Millimeter
Width8Millimeter

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
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
00643169588219Medtronic Resuable InstrumentsX08108352022-11-14
00643169860940Medtronic Resuable InstrumentsX07160322022-11-14
00643169860957Medtronic Resuable InstrumentsX07160332022-11-14
00613994107169Medtronic Reusable InstrumentsX08050732022-10-07
00613994230676Medtronic Reusable InstrumentsX07061412022-10-07
00613994404510Medtronic Reusable InstrumentsX07061942022-10-07
00613994507129Medtronic Reusable InstrumentsX08081362022-10-07
00613994507150Medtronic Reusable InstrumentsX08081392022-10-07
00613994507174Medtronic Reusable InstrumentsX08081412022-10-07
00613994838797Medtronic Reusable InstrumentsX06102712022-10-07
00613994838803Medtronic Reusable InstrumentsX06102702022-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08031497002842MectaCem BonePrepTECRES SPAJDK2022-11-17
07630345710963MectaPlug PE IIMedacta International SAJDK2021-04-16
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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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
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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