GIZA

Primary DI
07640167930265
Brand
GIZA
Company
Eden Spine Europe SA
Model
Corpectomy Implant GIZA D 21 T1 4°
Catalog number
GT102000S
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
07640167930265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640167930265076401679302657640167930265

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
07640167930012GIZACorpectomy implant Giza, Diam 14 mm, 18-22 mm, 2-548291482S2015-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00840283403460LumiVy™VY SPINE LLCMQP2026-06-05
00763000857844T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-01
00763000857943T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-01
00763000857998T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-01
00841732128231VALEO VBRCTL Medical CorporationMQP2023-09-27
00841732128248VALEO VBRCTL Medical CorporationMQP2023-09-27
07640172551103KONG-TL VBR System, Expansion Handleicotec AGMQP2020-06-19
07640172551110KONG-TL VBR System, Locking Rodicotec AGMQP2020-06-19
08033726407923DSCSINTEA PLUSTEK SRLMQP2015-10-16
08033726404250DSCSINTEA PLUSTEK SRLMQP2015-10-09
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08033726407664DSCSINTEA PLUSTEK SRLMQP2015-10-09
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08033726407718DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407725DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407732DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407749DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407756DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407763DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407770DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407787DSCSINTEA PLUSTEK SRLMQP2015-10-09
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08033726407800DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407817DSCSINTEA PLUSTEK SRLMQP2015-10-09
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