109-015-1532

GUDID 04250869607766

TELIX K Ti Cage 15x32mm 5°

Biedermann Motech GmbH & Co. KG

Metallic spinal interbody fusion cage
Primary Device ID04250869607766
NIH Device Record Key29a1020f-0f0e-4317-8d48-950640555ad9
Commercial Distribution StatusIn Commercial Distribution
Version Model Number109-015-1532
Catalog Number109-015-1532
Company DUNS320249162
Company NameBiedermann Motech GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104250869607766 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04250869607766]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-06
Device Publish Date2017-06-20

Devices Manufactured by Biedermann Motech GmbH & Co. KG

04250869696326 - NA2023-12-01 MOSS T-handle for final tightener, 11Nm, 1/4" coupling
04250869688475 - NA2023-11-30 MOSS VRS PSO Pliers Connector 50mm
04250869688482 - NA2023-11-30 MOSS VRS PSO Pliers Connector 75mm
04250869688512 - NA2023-11-30 MOSS VRS PSO Pliers connector 150mm
04250869688529 - NA2023-11-30 MOSS VRS PSO Pliers Blade right
04250869688536 - NA2023-11-30 MOSS VRS PSO Pliers Blade left
04250869688550 - NA2023-11-30 MOSS VRS PSO Valve adjustable, right
04250869688567 - NA2023-11-30 MOSS VRS PSO Valve adjustable, left

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