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

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component (KTT) (5) Orthosis, Spinal Pedicle Fixation (MNI) (5) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (5)

Premarket Exempt

Clear

Dyna-EXTOR Ⅱ EXTERNAL FIXATION SYSTEM - 08809155851633 Catalog Number :

Device Description : Dyna-EXTOR(M) Ⅱ, T Clamp

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Dyna-EXTOR Ⅱ EXTERNAL FIXATION SYSTEM - 08809155851640 Catalog Number :

Device Description : Dyna-EXTOR(M) Ⅱ, Lengthening Bar

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Dyna-EXTOR Ⅱ EXTERNAL FIXATION SYSTEM - 08809155852036 Catalog Number :

Device Description : Dyna-EXTOR(SM) Ⅱ, 8cm

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Dyna-EXTOR Ⅱ EXTERNAL FIXATION SYSTEM - 08809155852043 Catalog Number :

Device Description : Dyna-EXTOR(SM) Ⅱ, 11cm

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Dyna-EXTOR Ⅱ EXTERNAL FIXATION SYSTEM - 08809155852050 Catalog Number :

Device Description : Dyna-EXTOR(SM) Ⅱ, Forearm

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

DVX SPINE SYSTEM - 08809155852081 Catalog Number :

Device Description : Multi-axial Pedicle Screw, Ø5.5 x 35mm

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

DVX SPINE SYSTEM - 08809155852098 Catalog Number :

Device Description : Multi-axial Pedicle Screw, Ø5.5 x 40mm

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

DVX SPINE SYSTEM - 08809155852104 Catalog Number :

Device Description : Multi-axial Pedicle Screw, Ø5.5 x 45mm

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

DVX SPINE SYSTEM - 08809155852111 Catalog Number :

Device Description : Multi-axial Pedicle Screw, Ø5.5 x 50mm

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

DVX SPINE SYSTEM - 08809155852128 Catalog Number :

Device Description : Multi-axial Pedicle Screw, Ø5.5 x 55mm

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

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