TiLink-T 21-34100510

GUDID 00856037005279

TiLink-T - 34mm x 10mm x 10mm x 5 deg

Tyber Medical LLC

Metal-polymer composite spinal interbody fusion cage
Primary Device ID00856037005279
NIH Device Record Key31cd3556-3bc9-4ef0-97f4-f3c8515cef5a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTiLink-T
Version Model Number21-34100510
Catalog Number21-34100510
Company DUNS010968002
Company NameTyber Medical 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

Customer Support Contacts

Phone+1(866)761-0933
Emailjstigliano@tybermed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100856037005279 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-11-12

On-Brand Devices [TiLink-T]

00856037005316TiLink-T - 34mm x 10mm x 15mm x 5 deg
00856037005309TiLink-T - 34mm x 10mm x 13mm x 5 deg
00856037005293TiLink-T - 34mm x 10mm x 12mm x 5 deg
00856037005286TiLink-T - 34mm x 10mm x 11mm x 5 deg
00856037005279TiLink-T - 34mm x 10mm x 10mm x 5 deg
00856037005262TiLink-T - 34mm x 10mm x 9mm x 5 deg
00856037005255TiLink-T - 34mm x 10mm x 8mm x 5 deg
00856037005248TiLink-T - 34mm x 10mm x 7mm x 5 deg
00856037005231TiLink-T 30mm x 10mm x 15mm x 5 deg
00856037005224TiLink-T 30mm x 10mm x 13mm x 5 deg
00856037005217TiLink-T 30mm x 10mm x 12mm x 5 deg
00856037005200TiLink-T 30mm x 10mm x 11mm x 5 deg
00856037005194TiLink-T 30mm x 10mm x 10mm x 5 deg
00856037005187TiLink-T 30mm x 10mm x 9mm x 5 deg
00856037005170TiLink-T 30mm x 10mm x 8mm x 5 deg
00856037005163TiLink-T 30mm x 10mm x 7mm x 5 deg

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