ostaPek Interbody Fusion Cage

GUDID 07640173168065

PLIF bullet small

coLigne AG

Polymeric spinal interbody fusion cage
Primary Device ID07640173168065
NIH Device Record Key83973bc3-c916-44fb-8357-b941b3e2678b
Commercial Distribution StatusIn Commercial Distribution
Brand NameostaPek Interbody Fusion Cage
Version Model Number65.712
Company DUNS482467792
Company NamecoLigne AG
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+41433438000
Emailinfo@coligne.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107640173168065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640173168065]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-08-08

On-Brand Devices [ostaPek Interbody Fusion Cage]

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