FDA.reportPublic FDA data

ANATOMIC PEEK CERVICAL FUSION SYSTEM

Primary DI
00613994360472
Brand
ANATOMIC PEEK CERVICAL FUSION SYSTEM
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
4240286
Device description
IMPLANT 4240286 ANATOMIC C 18X16X 12MM
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
K112444000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112444000ANATOMIC PEEK CERVICAL FUSION SYSTEMMedtronic Sofamor Danck USA, Inc.2011-11-15ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994360472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994360472006139943604726139943604720613994360472

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth16Millimeter
Height12Millimeter
Width18Millimeter

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
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
00613994838841Medtronic Reusable InstrumentsX06102662022-10-07
00613994866011Medtronic Reusable InstrumentsX08108102022-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.ODP2026-09-22
07613327503968Aero-CStryker CorporationODP2019-12-18
10888857461819CASCADIA™ Interbody SystemVB Spine LLCODP2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCODP2019-10-31
07613327353921Aero-CStryker CorporationODP2018-06-28
07613327353938Aero-CStryker CorporationODP2018-06-28
07613327353945Aero-CStryker CorporationODP2018-06-28
07613327353952Aero-CStryker CorporationODP2018-06-28
07613327353976Aero-CStryker CorporationODP2018-06-28
07613327347036Tritanium CStryker CorporationODP2017-09-18
07613327347050Tritanium CStryker CorporationODP2017-09-18
07613327347067Tritanium CStryker CorporationODP2017-09-18
07613327347098Tritanium CStryker CorporationODP2017-09-18
07613327347159Tritanium CStryker CorporationODP2017-09-18
07613327347197Tritanium CStryker CorporationODP2017-09-18
07613327347296Tritanium CStryker CorporationODP2017-09-18
07613327347333Tritanium CStryker CorporationODP2017-09-18
07613327347357Tritanium CStryker CorporationODP2017-09-18
07613327347364Tritanium CStryker CorporationODP2017-09-18
07613327349535Tritanium CStryker CorporationODP2017-09-18
07613327360035Tritanium CStryker CorporationODP2017-09-18
07613327360103Tritanium CStryker CorporationODP2017-09-18
07613327360257Tritanium CStryker CorporationODP2017-09-18
07613327360363Tritanium CStryker CorporationODP2017-09-18
07613327360370Tritanium CStryker CorporationODP2017-09-18
07613327360516Tritanium CStryker CorporationODP2017-09-18