DIOMEDICAL CO.,LTD.

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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, spinal intervertebral body (KWQ) (10)

Premarket Exempt

Clear

Hana ACP - 08800039800518 Catalog Number : UP.FD.5114

Device Description : Fixed-angle screws (self-drilling) D5.1 x L14

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800525 Catalog Number : UP.FD.5116

Device Description : Fixed-angle screws (self-drilling) D5.1 x L16

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800532 Catalog Number : UP.FD.5118

Device Description : Fixed-angle screws (self-drilling) D5.1 x L18

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800549 Catalog Number : UP.FD.5120

Device Description : Fixed-angle screws (self-drilling) D5.1 x L20

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800556 Catalog Number : UP.FT.4612

Device Description : Fixed-angle screws (self-tapping) D4.6 x L12

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800563 Catalog Number : UP.FT.4614

Device Description : Fixed-angle screws (self-tapping) D4.6 x L14

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800570 Catalog Number : UP.FT.4616

Device Description : Fixed-angle screws (self-tapping) D4.6 x L16

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800587 Catalog Number : UP.FT.4618

Device Description : Fixed-angle screws (self-tapping) D4.6 x L18

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800594 Catalog Number : UP.FT.4620

Device Description : Fixed-angle screws (self-tapping) D4.6 x L20

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800600 Catalog Number : UP.FT.4622

Device Description : Fixed-angle screws (self-tapping) D4.6 x L22

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

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