LOSPA & LOSPA IS Spinal System

GUDID 08806373857089

LOSPA IS ALIF Cage(Non-sterile)

Corentec Co., Ltd

Polymeric spinal interbody fusion cage
Primary Device ID08806373857089
NIH Device Record Key799a8639-f0fb-46a1-9892-44bd642d7246
Commercial Distribution StatusIn Commercial Distribution
Brand NameLOSPA & LOSPA IS Spinal System
Version Model NumberSC.S02.2813
Company DUNS688739895
Company NameCorentec Co., Ltd
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+820415857114
Emailhckoh@corentec.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108806373857089 [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

[08806373857089]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2015-10-28

On-Brand Devices [LOSPA & LOSPA IS Spinal System]

08806373858055LOSPA IS ACIF Cage(Non-sterile)
08806373858048LOSPA IS ACIF Cage(Non-sterile)
08806373858031LOSPA IS ACIF Cage(Non-sterile)
08806373858024LOSPA IS ACIF Cage(Non-sterile)
08806373858017LOSPA IS ACIF Cage(Non-sterile)
08806373858000LOSPA IS ACIF Cage(Non-sterile)
08806373857997LOSPA IS ACIF Cage(Non-sterile)
08806373857980LOSPA IS ACIF Cage(Non-sterile)
08806373857973LOSPA IS ACIF Cage(Non-sterile)
08806373857966LOSPA IS ACIF Cage(Non-sterile)
08806373857959LOSPA IS ACIF Cage(Non-sterile)
08806373857942LOSPA IS ACIF Cage(Non-sterile)
08806373857935LOSPA IS ACIF Cage(Non-sterile)
08806373857928LOSPA IS ACIF Cage(Non-sterile)
08806373857911LOSPA IS ACIF Cage(Non-sterile)
08806373857904LOSPA IS ACIF Cage(Non-sterile)
08806373857898LOSPA IS ACIF Cage(Non-sterile)
08806373857881LOSPA IS ACIF Cage(Non-sterile)
08806373857874LOSPA IS ACIF Cage(Non-sterile)
08806373857867LOSPA IS ACIF Cage(Non-sterile)
08806373857850LOSPA IS ACIF Cage(Non-sterile)
08806373857843LOSPA IS ACIF Cage(Non-sterile)
08806373857836LOSPA IS ACIF Cage(Non-sterile)
08806373857829LOSPA IS ACIF Cage(Non-sterile)
08806373857256LOSPA IS ALIF Cage(Non-sterile)
08806373857249LOSPA IS ALIF Cage(Non-sterile)
08806373857232LOSPA IS ALIF Cage(Non-sterile)
08806373857225LOSPA IS ALIF Cage(Non-sterile)
08806373857218LOSPA IS ALIF Cage(Non-sterile)
08806373857201LOSPA IS ALIF Cage(Non-sterile)
08806373857195LOSPA IS ALIF Cage(Non-sterile)
08806373857188LOSPA IS ALIF Cage(Non-sterile)
08806373857171LOSPA IS ALIF Cage(Non-sterile)
08806373857164LOSPA IS ALIF Cage(Non-sterile)
08806373857157LOSPA IS ALIF Cage(Non-sterile)
08806373857140LOSPA IS ALIF Cage(Non-sterile)
08806373857133LOSPA IS ALIF Cage(Non-sterile)
08806373857126LOSPA IS ALIF Cage(Non-sterile)
08806373857119LOSPA IS ALIF Cage(Non-sterile)
08806373857102LOSPA IS ALIF Cage(Non-sterile)
08806373857096LOSPA IS ALIF Cage(Non-sterile)
08806373857089LOSPA IS ALIF Cage(Non-sterile)
08806373857072LOSPA IS ALIF Cage(Non-sterile)
08806373857065LOSPA IS ALIF Cage(Non-sterile)
08806373857058LOSPA IS ALIF Cage(Non-sterile)
08806373857041LOSPA IS ALIF Cage(Non-sterile)
08806373857034LOSPA IS ALIF Cage(Non-sterile)
08806373857027LOSPA IS ALIF Cage(Non-sterile)
08806373857010LOSPA IS ALIF Cage(Non-sterile)
08806373857003LOSPA IS ALIF Cage(Non-sterile)

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