TiLink-P 20-26100815

GUDID 00856037005156

TiLink-P 26mm x 10mm x 15mm x 8 deg

Tyber Medical LLC

Metal-polymer composite spinal interbody fusion cage
Primary Device ID00856037005156
NIH Device Record Key2468cee0-4790-4e77-bb7a-61482592a543
Commercial Distribution StatusIn Commercial Distribution
Brand NameTiLink-P
Version Model Number20-26100815
Catalog Number20-26100815
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
GS100856037005156 [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-P]

00856037005156TiLink-P 26mm x 10mm x 15mm x 8 deg
00856037005149TiLink-P 26mm x 10mm x 13mm x 8 deg
00856037005132TiLink-P 26mm x 10mm x 12mm x 8 deg
00856037005101TiLink-P 26mm x 10mm x 9mm x 8 deg
00856037005095TiLink-P 26mm x 10mm x 8mm x 8 deg
00856037005088TiLink-P 26mm x 10mm x 7mm x 8 deg
00856037005828TiLink-P - 26mm x 10mm x 9mm x 0°
00856037005811TiLink-P - 26mm x 10mm x 8mm x 0°
00856037005804TiLink-P - 26mm x 10mm x 12mm x 0°
00856037005798TiLink-P - 26mm x 10mm x 11mm x 0°
00856037005781TiLink-P - 26mm x 10mm x 10mm x 0°

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