CG Bio Co., Ltd.

Address:244, Galmachi-ro, Jungwon-gu,,Seongnam-si Gyeonggi,KR

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Orthosis, Spinal Pedicle Fixation (MNI) (10) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (10)

Premarket Exempt

Clear

LumFix Spinal Fixation System - 08809304756819 Catalog Number :

Device Description : Regulation Name: Pedicle screw spinal system

Device Class : 2

Duns Number: 631130655

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : No

Device Count : 1

LumFix Spinal Fixation System - 08809304756987 Catalog Number :

Device Description : Regulation Name: Pedicle screw spinal system

Device Class : 2

Duns Number: 631130655

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : No

Device Count : 1

LumFix Spinal Fixation System - 08809304756994 Catalog Number :

Device Description : Regulation Name: Pedicle screw spinal system

Device Class : 2

Duns Number: 631130655

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : No

Device Count : 1

LumFix Spinal Fixation System - 08809304757007 Catalog Number :

Device Description : Regulation Name: Pedicle screw spinal system

Device Class : 2

Duns Number: 631130655

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : No

Device Count : 1

LumFix Spinal Fixation System - 08809304757687 Catalog Number :

Device Description : Regulation Name: Pedicle screw spinal system

Device Class : 2

Duns Number: 631130655

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : No

Device Count : 1

LumFix Spinal Fixation System - 08809429610904 Catalog Number :

Device Description : Regulation Name: Pedicle screw spinal system

Device Class : 2

Duns Number: 631130655

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : No

Device Count : 1

LumFix Spinal Fixation System - 08809429611017 Catalog Number :

Device Description : Regulation Name: Pedicle screw spinal system

Device Class : 2

Duns Number: 631130655

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : No

Device Count : 1

LumFix Spinal Fixation System - 08809429611024 Catalog Number :

Device Description : Regulation Name: Pedicle screw spinal system

Device Class : 2

Duns Number: 631130655

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : No

Device Count : 1

LumFix Spinal Fixation System - 08809429611031 Catalog Number :

Device Description : Regulation Name: Pedicle screw spinal system

Device Class : 2

Duns Number: 631130655

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : No

Device Count : 1

LumFix Spinal Fixation System - 08809429611130 Catalog Number :

Device Description : Regulation Name: Pedicle screw spinal system

Device Class : 2

Duns Number: 631130655

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : No

Device Count : 1

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