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 - 08800039800419 Catalog Number : UP.VT.5120

Device Description : Variable-angle screws (self-tapping) D5.1 x L20

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800426 Catalog Number : UP.VT.5122

Device Description : Variable-angle screws (self-tapping) D5.1 x L22

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800433 Catalog Number : UP.VT.5124

Device Description : Variable-angle screws (self-tapping) D5.1 x L24

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800440 Catalog Number : UP.VT.5126

Device Description : Variable-angle screws (self-tapping) D5.1 x L26

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800457 Catalog Number : UP.FD.4612

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

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800464 Catalog Number : UP.FD.4614

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

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800471 Catalog Number : UP.FD.4616

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

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800488 Catalog Number : UP.FD.4618

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

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800495 Catalog Number : UP.FD.4620

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

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Hana ACP - 08800039800501 Catalog Number : UP.FD.5112

Device Description : Fixed-angle screws (self-drilling) D5.1 x L12

Device Class : 2

Duns Number: 557795909

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

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