FDA.reportPublic FDA data

CORNERSTONE® PSR Cervical Fusion System

Primary DI
00613994367433
Brand
CORNERSTONE® PSR Cervical Fusion System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
6284144
Device description
IMPLANT 6284144 PEEK CRV 14X14X 11MM
Published
2015-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ODPIntervertebral fusion device with bone graft, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100214000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100214000CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICEMedtronic Sofamor Danek2010-06-25ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994367433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994367433006139943674336139943674330613994367433

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal fusion cage, sterileA sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth14Millimeter
Height11Millimeter
Width14Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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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
00613994838841Medtronic Reusable InstrumentsX06102662022-10-07
00613994866011Medtronic Reusable InstrumentsX08108102022-10-07

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