109-015-1032

GUDID 04250869607711

TELIX K Ti Cage 10x32mm 5°

Biedermann Motech GmbH & Co. KG

Metallic spinal interbody fusion cage
Primary Device ID04250869607711
NIH Device Record Key1e5f5167-cf64-4dac-8aff-e208b748392b
Commercial Distribution StatusIn Commercial Distribution
Version Model Number109-015-1032
Catalog Number109-015-1032
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
GS104250869607711 [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

[04250869607711]

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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04250869636179 - NA2024-06-28 MOSS VRS Ti rod, Ø6.0x600mm, straight, hex on both sides, size 4.3
04250869654050 - NA2024-06-28 MOSS VRS Locking Cap Final Tightener HP, 1/4" coupl., 223mm, ISR27
04250869633420 - NA2024-06-26 MOSS 100 Caddy Rods
04250869654067 - NA2024-06-26 MOSS VRS Locking Cap Final Tightener HP, 1/4" coupl., 273mm, ISR27
04250869654234 - NA2024-06-26 MOSS 100 Ø9.0mm Tap, DL, 1/4" coupling, strengthened, pink

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