109-015-1228

GUDID 04250869607667

TELIX K Ti Cage 12x28mm 5°

Biedermann Motech GmbH & Co. KG

Metallic spinal interbody fusion cage
Primary Device ID04250869607667
NIH Device Record Key94876fcb-ff7d-4ea4-a984-77209f0c758c
Commercial Distribution StatusIn Commercial Distribution
Version Model Number109-015-1228
Catalog Number109-015-1228
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
GS104250869607667 [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

[04250869607667]

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

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