GIZA

Primary DI
07640167930012
Brand
GIZA
Company
Eden Spine Europe SA
Model
Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 2-5
Catalog number
48291482S
Device description
The GIZA is a spinal vertebral body replacement device.
Published
2015-09-24
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

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
K112429000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112429000GIZA(R) VERTEBRAL BODY REPLACEMENTEden Spine, LLC2012-01-26MQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640167930012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640167930012076401679300127640167930012

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral body prosthesisAn implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
482797425
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640167930180GIZAGiza Instruments tray lid482934012018-09-24
07640167930197GIZAGiza Instruments tray with silicone inserts482934002018-09-24
07640167930456GIZAGiza Instruments tray lid1009W2018-09-24
07640167930463GIZAGiza Instruments tray with silicone inserts1009V2018-09-24
07640167930074GIZAGiza- Holder distractor Lg 220 mm482932202018-09-24
07640167930081GIZAGiza- Holder distractor Lg 320 mm482933202018-09-24
07640167930098GIZAGiza Removable holder distractor tip Ø 14 mm482930142018-09-24
07640167930159GIZAGiza Implant holding block482934042018-09-24
07640167930326GIZAGiza- Holder distractor Lg 220 mm100232018-09-24
07640167930333GIZAGiza- Holder distractor Lg 320 mm1009U2018-09-24
07640167930340GIZAGiza Removable holder distractor tip Ø 14 mm100242018-09-24
07640167930357GIZAGiza Removable holder distractor tip Ø 21 mm100252018-09-24
07640167930364GIZAGiza Removable holder distractor tip Ø 27 mm100262018-09-24
07640167930425GIZAGiza Implant holding block1009Y2018-09-24
07640167930029GIZACorpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-848291485S2015-09-24
07640167930036GIZACorpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-548291422S2015-09-24
07640167930043GIZACorpectomy implant Giza, Diam 14 mm, 23-32 mm, 7-148291427S2015-09-24
07640167930050GIZACorpectomy implant Giza, Diam 14 mm, 33-54 mm, 2-548291432S2015-09-24
07640167930067GIZACorpectomy implant Giza, Diam 14 mm, 33-54 mm, 7-148291437S2015-09-24
07640167930265GIZACorpectomy Implant GIZA D 21 T1 4°GT102000S2015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857461819CASCADIA™ Interbody SystemVB Spine LLCMQP2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCMQP2019-10-31
10888857218772CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
10888857219489CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
10888857219595CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
04546540389084VBOSSStryker CorporationMQP2015-09-14
04546540389091VBOSSStryker CorporationMQP2015-09-14
04546540389107VBOSSStryker CorporationMQP2015-09-14
04546540389114VBOSSStryker CorporationMQP2015-09-14
04546540389121VBOSSStryker CorporationMQP2015-09-14
04546540389138VBOSSStryker CorporationMQP2015-09-14
04546540389145VBOSSStryker CorporationMQP2015-09-14
04546540389152VBOSSStryker CorporationMQP2015-09-14
04546540389169VBOSSStryker CorporationMQP2015-09-14
04546540389176VBOSSStryker CorporationMQP2015-09-14
04546540389183VBOSSStryker CorporationMQP2015-09-14
04546540389190VBOSSStryker CorporationMQP2015-09-14
04546540389206VBOSSStryker CorporationMQP2015-09-14
04546540389213VBOSSStryker CorporationMQP2015-09-14
04546540389220VBOSSStryker CorporationMQP2015-09-14
04546540389237VBOSSStryker CorporationMQP2015-09-14
04546540389244VBOSSStryker CorporationMQP2015-09-14
04546540389251VBOSSStryker CorporationMQP2015-09-14
04546540389268VBOSSStryker CorporationMQP2015-09-14
04546540389275VBOSSStryker CorporationMQP2015-09-14
04546540389282VBOSSStryker CorporationMQP2015-09-14
04546540389299VBOSSStryker CorporationMQP2015-09-14
04546540389305VBOSSStryker CorporationMQP2015-09-14