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) (10)

Premarket Exempt

Clear

Dyna-EXTOR Ⅱ EXTERNAL FIXATION SYSTEM - 08809155851251 Catalog Number :

Device Description : Dyna-EXTOR(L) Ⅱ, Bar to Bar Connector

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Dyna-EXTOR Ⅱ EXTERNAL FIXATION SYSTEM - 08809155851275 Catalog Number :

Device Description : Dyna-EXTOR(L) Ⅱ, Standard-Type

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Dyna-EXTOR Ⅱ EXTERNAL FIXATION SYSTEM - 08809155851282 Catalog Number :

Device Description : Dyna-EXTOR(L) Ⅱ, T-Type

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Dyna-EXTOR Ⅱ EXTERNAL FIXATION SYSTEM - 08809155851299 Catalog Number :

Device Description : Dyna-EXTOR(L) Ⅱ, Standard 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 - 08809155851305 Catalog Number :

Device Description : Dyna-EXTOR(L) 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 - 08809155851312 Catalog Number :

Device Description : Dyna-EXTOR(L) Ⅱ, Bar-Ring 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 - 08809155851329 Catalog Number :

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

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Dyna-EXTOR Ⅱ EXTERNAL FIXATION SYSTEM - 08809155851336 Catalog Number :

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

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Dyna-EXTOR Ⅱ EXTERNAL FIXATION SYSTEM - 08809155851343 Catalog Number :

Device Description : Dyna-EXTOR(L) Ⅱ, Ankle 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 - 08809155851350 Catalog Number :

Device Description : Dyna-EXTOR(L) Ⅱ, Single Clamp

Device Class : 2

Duns Number: 687941818

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

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