BK MEDITECH CO.,LTD.

Address:58, Eunhaengnamu-ro, Yanggam-myeon,Hwaseong-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

DVX SPINE SYSTEM - 08809155852135 Catalog Number :

Device Description : Multi-axial Pedicle Screw, Ø5.5 x 60mm

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

DVX SPINE SYSTEM - 08809155852159 Catalog Number :

Device Description : Multi-axial Pedicle Screw, Ø6.5 x 35mm

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

DVX SPINE SYSTEM - 08809155852166 Catalog Number :

Device Description : Multi-axial Pedicle Screw, Ø6.5 x 40mm

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

DVX SPINE SYSTEM - 08809155852173 Catalog Number :

Device Description : Multi-axial Pedicle Screw, Ø6.5 x 45mm

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

DVX SPINE SYSTEM - 08809155852180 Catalog Number :

Device Description : Multi-axial Pedicle Screw, Ø6.5 x 50mm

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

DVX SPINE SYSTEM - 08809155852197 Catalog Number :

Device Description : Multi-axial Pedicle Screw, Ø6.5 x 55mm

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

DVX SPINE SYSTEM - 08809155852203 Catalog Number :

Device Description : Multi-axial Pedicle Screw, Ø6.5 x 60mm

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

DVX SPINE SYSTEM - 08809155852227 Catalog Number :

Device Description : Multi-axial Pedicle Screw, Ø7.5 x 35mm

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

DVX SPINE SYSTEM - 08809155852234 Catalog Number :

Device Description : Multi-axial Pedicle Screw, Ø7.5 x 40mm

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

DVX SPINE SYSTEM - 08809155852241 Catalog Number :

Device Description : Multi-axial Pedicle Screw, Ø7.5 x 45mm

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

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