Mecta-C Ti mark

GUDID 07630040718059

Cervical Interbody Fusion Device “Dome shaped” 12x16x6 L5°- Ti markers

Medacta International SA

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

Primary Device ID	07630040718059
NIH Device Record Key	2b1bf093-127c-4a33-b5c3-e6a922666ff1
Commercial Distribution Status	In Commercial Distribution
Brand Name	Mecta-C Ti mark
Version Model Number	03.28.115
Company DUNS	488227125
Company Name	Medacta International SA
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630040718059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K172587

FDA Product Code

ODP	Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-11-02
Device Publish Date	2021-10-25

On-Brand Devices [Mecta-C Ti mark]

07630040718806	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 15x18x9 L5°- Ti markers
07630040718790	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 15x18x8 L5°- Ti markers
07630040718783	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 15x18x7 L5°- Ti markers
07630040718776	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 15x18x6 L5°- Ti markers
07630040718769	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 15x18x5 L5°- Ti markers
07630040718752	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 15x18x4 L5°- Ti markers
07630040718745	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 14x16x9 L5°- Ti markers
07630040718738	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 14x16x8 L5°- Ti markers
07630040718721	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 14x16x7 L5°- Ti markers
07630040718714	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 14x16x6 L5°- Ti markers
07630040718707	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 14x16x5 L5°- Ti markers
07630040718691	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 14x16x4 L5°- Ti markers
07630040718684	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 12x16x9 L5°- Ti markers
07630040718677	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 12x16x8 L5°- Ti markers
07630040718660	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 12x16x7 L5°- Ti markers
07630040718653	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 12x16x6 L5°- Ti markers
07630040718646	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 12x16x5 L5°- Ti markers
07630040718639	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 12x16x4 L5°- Ti markers
07630040718622	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 14x14x9 L5°- Ti markers
07630040718615	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 14x14x8 L5°- Ti markers
07630040718608	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 14x14x7 L5°- Ti markers
07630040718592	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 14x14x6 L5°- Ti markers
07630040718585	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 14x14x5 L5°- Ti markers
07630040718578	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 14x14x4 L5°- Ti markers
07630040718561	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 12x14x9 L5°- Ti markers
07630040718554	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 12x14x8 L5°- Ti markers
07630040718547	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 12x14x7 L5°- Ti markers
07630040718530	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 12x14x6 L5°- Ti markers
07630040718523	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 12x14x5 L5°- Ti markers
07630040718516	Cervical Interbody Fusion Device TiPEEK “Dome shaped” 12x14x4 L5°- Ti markers
07630040718509	Cervical Interbody Fusion Device TiPEEK “Flat” 15x18x9 L7°- Ti markers
07630040718493	Cervical Interbody Fusion Device TiPEEK “Flat” 15x18x8 L7°- Ti markers
07630040718486	Cervical Interbody Fusion Device TiPEEK “Flat” 15x18x7 L7°- Ti markers
07630040718479	Cervical Interbody Fusion Device TiPEEK “Flat” 15x18x6 L7°- Ti markers
07630040718462	Cervical Interbody Fusion Device TiPEEK “Flat” 15x18x5 L7°- Ti markers
07630040718455	Cervical Interbody Fusion Device TiPEEK “Flat” 15x18x4 L7°- Ti markers
07630040718448	Cervical Interbody Fusion Device TiPEEK “Flat” 14x16x9 L7°- Ti markers
07630040718431	Cervical Interbody Fusion Device TiPEEK “Flat” 14x16x8 L7°- Ti markers
07630040718424	Cervical Interbody Fusion Device TiPEEK “Flat” 14x16x7 L7°- Ti markers
07630040718417	Cervical Interbody Fusion Device TiPEEK “Flat” 14x16x6 L7°- Ti markers
07630040718400	Cervical Interbody Fusion Device TiPEEK “Flat” 14x16x5 L7°- Ti markers
07630040718394	Cervical Interbody Fusion Device TiPEEK “Flat” 14x16x4 L7°- Ti markers
07630040718387	Cervical Interbody Fusion Device TiPEEK “Flat” 12x16x9 L7°- Ti markers
07630040718370	Cervical Interbody Fusion Device TiPEEK “Flat” 12x16x8 L7°- Ti markers
07630040718363	Cervical Interbody Fusion Device TiPEEK “Flat” 12x16x7 L7°- Ti markers
07630040718356	Cervical Interbody Fusion Device TiPEEK “Flat” 12x16x6 L7°- Ti markers
07630040718349	Cervical Interbody Fusion Device TiPEEK “Flat” 12x16x5 L7°- Ti markers
07630040718332	Cervical Interbody Fusion Device TiPEEK “Flat” 12x16x4 L7°- Ti markers
07630040718325	Cervical Interbody Fusion Device TiPEEK “Flat” 14x14x9 L7°- Ti markers
07630040718318	Cervical Interbody Fusion Device TiPEEK “Flat” 14x14x8 L7°- Ti markers