TiLink-C 30-14120508

GUDID 00856037005033

TiLink-C 14mm x 8mm x 5 deg Curved

Tyber Medical LLC

Metal-polymer composite spinal interbody fusion cage
Primary Device ID00856037005033
NIH Device Record Key759f8052-a8a1-4226-a234-b800569edc01
Commercial Distribution StatusIn Commercial Distribution
Brand NameTiLink-C
Version Model Number30-14120508
Catalog Number30-14120508
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
GS100856037005033 [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-C]

00856037005071TiLink-C 14mm x 12mm x 5 deg Curved
00856037005064TiLink-C 14mm x 11mm x 5 deg Curved
00856037005057TiLink-C 14mm x 10mm x 5 deg Curved
00856037005040TiLink-C 14mm x 9mm x 5 deg Curved
00856037005033TiLink-C 14mm x 8mm x 5 deg Curved
00856037005026TiLink-C 14mm x 7mm x 5 deg Curved
00856037005019TiLink-C 14mm x 6mm x 5 deg Curved
00856037005002TiLink-C 14mm x 5mm x 5 deg Curved

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