LOSPA IS Spinal Fixation System

GUDID 08800017242125

CANNULATED POLYAXIAL PEDICLE SCREW - standard type Ø7.5 X 35, Length16.2mm

Corentec Co., Ltd

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID08800017242125
NIH Device Record Key11144e66-e5b9-40eb-bc8b-e45dd70f761d
Commercial Distribution Discontinuation2020-03-17
Commercial Distribution StatusNot in Commercial Distribution
Brand NameLOSPA IS Spinal Fixation System
Version Model NumberSA.608.7535
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+82414107176
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS108800017242125 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800017242125]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-25
Device Publish Date2020-03-17

On-Brand Devices [LOSPA IS Spinal Fixation System]

08800017249490POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 75, Length 15.5mm
08800017249483POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 70, Length 15.5mm
08800017249476POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 65, Length 15.5mm
08800017249469POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 60, Length 15.5mm
08800017249452POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 55, Length 15.5mm
08800017249445POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 50, Length 15.5mm
08800017249438POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 45, Length 15.5mm
08800017249421POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 40, Length 15.5mm
08800017249414POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 35, Length 15.5mm
08800017249407POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 30, Length 15.5mm
08800017249391POLYAXIAL PEDICLE SCREW II - standard type Ø6.0 X 25, Length 15.5mm
08800017249384POLYAXIAL PEDICLE SCREW II - standard type Ø5.5 X 55, Length 15.5mm
08800017249377POLYAXIAL PEDICLE SCREW II - standard type Ø5.5 X 50, Length 15.5mm
08800017249360POLYAXIAL PEDICLE SCREW II - standard type Ø5.5 X 45, Length 15.5mm
08800017249353POLYAXIAL PEDICLE SCREW II - standard type Ø5.5 X 40, Length 15.5mm
08800017249346POLYAXIAL PEDICLE SCREW II - standard type Ø5.5 X 35, Length 15.5mm
08800017249339POLYAXIAL PEDICLE SCREW II - standard type Ø5.5 X 30, Length 15.5mm
08800017249322POLYAXIAL PEDICLE SCREW II - standard type Ø5.5 X 25, Length 15.5mm
08800017249315POLYAXIAL PEDICLE SCREW II - standard type Ø5.5 X 20, Length 15.5mm
08800017249308POLYAXIAL PEDICLE SCREW II - standard type Ø5.0 X 55, Length 15.5mm
08800017249292POLYAXIAL PEDICLE SCREW II - standard type Ø5.0 X 50, Length 15.5mm
08800017249285POLYAXIAL PEDICLE SCREW II - standard type Ø5.0 X 45, Length 15.5mm
08800017249278POLYAXIAL PEDICLE SCREW II - standard type Ø5.0 X 40, Length 15.5mm
08800017249261POLYAXIAL PEDICLE SCREW II - standard type Ø5.0 X 35, Length 15.5mm
08800017249254POLYAXIAL PEDICLE SCREW II - standard type Ø5.0 X 30, Length 15.5mm
08800017249247POLYAXIAL PEDICLE SCREW II - standard type Ø5.0 X 25, Length 15.5mm
08800017249230POLYAXIAL PEDICLE SCREW II - standard type Ø5.0 X 20, Length 15.5mm
08800017249223POLYAXIAL PEDICLE SCREW II - standard type Ø4.5 X 55, Length 15.5mm
08800017249216POLYAXIAL PEDICLE SCREW II - standard type Ø4.5 X 50, Length 15.5mm
08800017249209POLYAXIAL PEDICLE SCREW II - standard type Ø4.5 X 45, Length 15.5mm
08800017249193POLYAXIAL PEDICLE SCREW II - standard type Ø4.5 X 40, Length 15.5mm
08800017249186POLYAXIAL PEDICLE SCREW II - standard type Ø4.5 X 35, Length 15.5mm
08800017249179POLYAXIAL PEDICLE SCREW II - standard type Ø4.5 X 30, Length 15.5mm
08800017249162POLYAXIAL PEDICLE SCREW II - standard type Ø4.5 X 25, Length 15.5mm
08800017249155POLYAXIAL PEDICLE SCREW II - standard type Ø4.5 X 20, Length 15.5mm
08800017249148POLYAXIAL PEDICLE SCREW II - standard type Ø4.0 X 55, Length 15.5mm
08800017259086POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 140, Length 28.2mm
08800017259079POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 135, Length 28.2mm
08800017259062POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 130, Length 28.2mm
08800017259055POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 125, Length 28.2mm
08800017259048POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 120, Length 28.2mm
08800017259031POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 115, Length 28.2mm
08800017259024POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 110, Length 28.2mm
08800017259017POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 105, Length 28.2mm
08800017259000POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 100, Length 28.2mm
08800017258997POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 95, Length 28.2mm
08800017258980POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 90, Length 28.2mm
08800017258973POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 85, Length 28.2mm
08800017258966POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 80, Length 28.2mm
08800017258959POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø9.5 X 75, Length 28.2mm

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