TALOS° HA PEEK IBF

GUDID B1676221713150

MEDITECH SPINE, LLC

Polymeric spinal interbody fusion cage
Primary Device IDB1676221713150
NIH Device Record Keya2cb52a7-97c0-4377-b267-b6dd1bc36c8a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTALOS° HA PEEK IBF
Version Model Number6-221713-15
Company DUNS182698477
Company NameMEDITECH SPINE, LLC
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB1676221713150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-23
Device Publish Date2020-03-15

On-Brand Devices [TALOS° HA PEEK IBF]

B16762217191506-221719-15
B16762217190706-221719-07
B16762217190006-221719-00
B16762217181506-221718-15
B16762217180706-221718-07
B16762217180006-221718-00
B16762217171506-221717-15
B16762217170706-221717-07
B16762217170006-221717-00
B16762217161506-221716-15
B16762217160706-221716-07
B16762217160006-221716-00
B16762217151506-221715-15
B16762217150706-221715-07
B16762217150006-221715-00
B16762217141506-221714-15
B16762217140706-221714-07
B16762217140006-221714-00
B16762217131506-221713-15
B16762217130706-221713-07
B16762217130006-221713-00
B16762217121506-221712-15
B16762217120706-221712-07
B16762217120006-221712-00
B16762217111506-221711-15
B16762217110706-221711-07
B16762217110006-221711-00
B16762217101506-221710-15
B16762217100706-221710-07
B16762217100006-221710-00
B16762217091506-221709-15
B16762217090706-221709-07
B16762217090006-221709-00
B16762217081506-221708-15
B16762217080706-221708-07
B16762217080006-221708-00
B16762217071506-221707-15
B16762217070706-221707-07
B16762217070006-221707-00
B16762216191506-221619-15
B16762216190706-221619-07
B16762216190006-221619-00
B16762216181506-221618-15
B16762216180706-221618-07
B16762216180006-221618-00
B16762216171506-221617-15
B16762216170706-221617-07
B16762216170006-221617-00
B16762216161506-221616-15
B16762216160706-221616-07

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