LOSPA IS Spinal System

GUDID 08800017219509

LOSPA IS ACP RST 1 Level (Sterile)

Corentec Co., Ltd

Spinal fixation plate, non-bioabsorbable
Primary Device ID08800017219509
NIH Device Record Keyab7520c5-6600-4812-84de-b45d0b0f8627
Commercial Distribution StatusIn Commercial Distribution
Brand NameLOSPA IS Spinal System
Version Model NumberSM.C51.0380
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 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+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com
Phone+820415857114
Emailhckoh@corentec.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108800017219509 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-09-18
Device Publish Date2017-04-06

On-Brand Devices [LOSPA IS Spinal System]

08800017222936LOSPA IS DLIF Cage (Non-sterile)
08800017222929LOSPA IS DLIF Cage (Non-sterile)
08800017222912LOSPA IS DLIF Cage (Non-sterile)
08800017222905LOSPA IS DLIF Cage (Non-sterile)
08800017222899LOSPA IS DLIF Cage (Non-sterile)
08800017222882LOSPA IS DLIF Cage (Non-sterile)
08800017222875LOSPA IS DLIF Cage (Non-sterile)
08800017222868LOSPA IS DLIF Cage (Non-sterile)
08800017222851LOSPA IS DLIF Cage (Non-sterile)
08800017222844LOSPA IS DLIF Cage (Non-sterile)
08800017222837LOSPA IS DLIF Cage (Non-sterile)
08800017222820LOSPA IS DLIF Cage (Non-sterile)
08800017222813LOSPA IS DLIF Cage (Non-sterile)
08800017222806LOSPA IS DLIF Cage (Non-sterile)
08800017222790LOSPA IS DLIF Cage (Non-sterile)
08800017222783LOSPA IS DLIF Cage (Non-sterile)
08800017222776LOSPA IS DLIF Cage (Non-sterile)
08800017222769LOSPA IS DLIF Cage (Non-sterile)
08800017222752LOSPA IS DLIF Cage (Non-sterile)
08800017222745LOSPA IS DLIF Cage (Non-sterile)
08800017222738LOSPA IS DLIF Cage (Non-sterile)
08800017222721LOSPA IS DLIF Cage (Non-sterile)
08800017222714LOSPA IS DLIF Cage (Non-sterile)
08800017222707LOSPA IS DLIF Cage (Non-sterile)
08800017222691LOSPA IS DLIF Cage (Non-sterile)
08800017222684LOSPA IS DLIF Cage (Non-sterile)
08800017222677LOSPA IS DLIF Cage (Non-sterile)
08800017222660LOSPA IS DLIF Cage (Non-sterile)
08800017222653LOSPA IS DLIF Cage (Non-sterile)
08800017222646LOSPA IS DLIF Cage (Non-sterile)
08800017222639LOSPA IS DLIF Cage (Non-sterile)
08800017222622LOSPA IS DLIF Cage (Non-sterile)
08800017222615LOSPA IS DLIF Cage (Non-sterile)
08800017222608LOSPA IS DLIF Cage (Non-sterile)
08800017222592LOSPA IS DLIF Cage (Non-sterile)
08800017222585LOSPA IS DLIF Cage (Non-sterile)
08800017222578LOSPA IS DLIF Cage (Non-sterile)
08800017222561LOSPA IS DLIF Cage (Non-sterile)
08800017222554LOSPA IS DLIF Cage (Non-sterile)
08800017222547LOSPA IS DLIF Cage (Non-sterile)
08800017222530LOSPA IS DLIF Cage (Non-sterile)
08800017222523LOSPA IS DLIF Cage (Non-sterile)
08800017222516LOSPA IS DLIF Cage (Non-sterile)
08800017222509LOSPA IS DLIF Cage (Non-sterile)
08800017222493LOSPA IS DLIF Cage (Non-sterile)
08800017222486LOSPA IS DLIF Cage (Non-sterile)
08800017222479LOSPA IS DLIF Cage (Non-sterile)
08800017222462LOSPA IS DLIF Cage (Non-sterile)
08800017222455LOSPA IS DLIF Cage (Non-sterile)
08800017222448LOSPA IS DLIF Cage (Non-sterile)

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