FDA.reportPublic FDA data

Mecta-C Cervical Cages

Primary DI
07630030832222
Brand
Mecta-C Cervical Cages
Company
Medacta International SA
Model
03.28.430
Device description
Cervical Interbody Fusion Device Flat 15x18x9 L7°
Published
2014-11-18
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
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
K112862000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112862000MECTA-CMedacta International2011-12-19ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630030832222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630030832222076300308322227630030832222

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
488227125
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630040795166Surgical Manual Instrument02.12.10.08452026-09-25
07630542792359Surgical Manual Instrument02.12.10.31272026-09-25
07630040738767Surgical Manual Instrument01.22.10.00512026-09-21
07630345706584M-Vizion Femoral Revision System Extension01.22.10.07812026-09-21
07630345706591M-Vizion Femoral Revision System Extension01.22.10.07822026-09-21
07630345706607M-Vizion Femoral Revision System Extension01.22.10.07832026-09-21
07630345706614M-Vizion Femoral Revision System Extension01.22.10.07842026-09-21
07630345706621M-Vizion Femoral Revision System Extension01.22.10.07852026-09-21
07630345706638M-Vizion Femoral Revision System Extension01.22.10.07862026-09-21
07630345706645M-Vizion Femoral Revision System Extension01.22.10.07872026-09-21
07630345706652M-Vizion Femoral Revision System Extension01.22.10.07882026-09-21
07630345706669M-Vizion Femoral Revision System Extension01.22.10.07892026-09-21
07630345706676M-Vizion Femoral Revision System Extension01.22.10.07902026-09-21
07630345706683M-Vizion Femoral Revision System Extension01.22.10.07912026-09-21
07630345706690M-Vizion Femoral Revision System Extension01.22.10.07922026-09-21
07630345706706M-Vizion Femoral Revision System Extension01.22.10.07932026-09-21
07630345706713M-Vizion Femoral Revision System Extension01.22.10.07942026-09-21
07630345706720M-Vizion Femoral Revision System Extension01.22.10.07952026-09-21
07630542702112Surgical Manual Instrument01.22.10.01742026-09-21
07630542723162M-Vizion Femoral Revision System Extension01.22.10.04022026-09-21

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