PLIF Interbody System 20-502-P241488-S

GUDID M69520502P241488S0

PLIF TiPEEK 24mm x 8mm x 14mm x 8 deg

Tyber Medical LLC

Metal-polymer composite spinal interbody fusion cage
Primary Device IDM69520502P241488S0
NIH Device Record Key421a27dc-3274-47a9-ab10-ed5a1dabf5fa
Commercial Distribution StatusIn Commercial Distribution
Brand NamePLIF Interbody System
Version Model Number20-502-P241488-S
Catalog Number20-502-P241488-S
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
HIBCCM69520502P241488S0 [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 [PLIF Interbody System]

M69520502P269810S0PLIF TiPEEK 26mm x 10mm x 9mm x 8 deg
M69520502P26888S0PLIF TiPEEK 26mm x 8mm x 8mm x 8 deg
M69520502P268810S0PLIF TiPEEK 26mm x 10mm x 8mm x 8 deg
M69520502P267810S0PLIF TiPEEK 26mm x 10mm x 7mm x 8 deg
M69520502P2612810S0PLIF TiPEEK 26mm x 10mm x 12mm x 8 deg
M69520502P2611810S0PLIF TiPEEK 26mm x 10mm x 11mm x 8 deg
M69520502P2610810S0PLIF TiPEEK 26mm x 10mm x 10mm x 8 deg
M69520502P24988S0PLIF TiPEEK 24mm x 8mm x 9mm x 8 deg
M69520502P241488S0PLIF TiPEEK 24mm x 8mm x 14mm x 8 deg
M69520502P241388S0PLIF TiPEEK 24mm x 8mm x 13mm x 8 deg
M69520502P241288S0PLIF TiPEEK 24mm x 8mm x 12mm x 8 deg
M69520502P241088S0PLIF TiPEEK 24mm x 8mm x 10mm x 8 deg

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