OSTEONIC CO.,Ltd.

Address:405, 505-2, 505-3, 508, 902, 1004, 1005, 1201, 1202, 1206Ho, 38, Digital-ro 29-gil,Seoul,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

Fastener, Fixation, Nondegradable, Soft Tissue (MBI) (10) Fastener, Fixation, Biodegradable, Soft Tissue (MAI) (1)

Premarket Exempt

No Yes

Clear

Fix2Lock - 08809595976910 Catalog Number :

Device Description : PEEK Lateral Lateral anchor '5.5' 1Line(Teleflex)(USP#2)(White/Blue 1)

Device Class : 2

Duns Number: 688999370

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

Fix2Lock - 08809595976927 Catalog Number :

Device Description : PEEK Healmax Lateral anchor '5.5' 1Line(Teleflex)(USP#2)(White)

Device Class : 2

Duns Number: 688999370

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

Fix2Lock - 08809595976934 Catalog Number :

Device Description : PEEK Healmax Lateral anchor '5.5' 1Line(Teleflex)(USP#2)(Blue 1)

Device Class : 2

Duns Number: 688999370

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

Fix2Lock - 08809595976941 Catalog Number :

Device Description : PEEK Healmax Lateral anchor '5.5' 1Line(Teleflex)(USP#2)(White/Black)

Device Class : 2

Duns Number: 688999370

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

Fix2Lock - 08809595976958 Catalog Number :

Device Description : PEEK Healmax Lateral anchor '5.5' 1Line(Teleflex)(USP#2)(White/Blue 1)

Device Class : 2

Duns Number: 688999370

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

Fix2Lock - 08809595976965 Catalog Number :

Device Description : PEEK Healmax Lateral anchor '4.5' 1Line(Teleflex)(USP#2)(White)

Device Class : 2

Duns Number: 688999370

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

Fix2Lock - 08809595976972 Catalog Number :

Device Description : PEEK Healmax Lateral anchor '4.5' 1Line(Teleflex)(USP#2)(Blue 1)

Device Class : 2

Duns Number: 688999370

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

Fix2Lock - 08809595976989 Catalog Number :

Device Description : PEEK Healmax Lateral anchor '4.5' 1Line(Teleflex)(USP#2)(White/Black)

Device Class : 2

Duns Number: 688999370

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

Fix2Lock - 08809595976996 Catalog Number :

Device Description : PEEK Healmax Lateral anchor '4.5' 1Line(Teleflex)(USP#2)(White/Blue 1)

Device Class : 2

Duns Number: 688999370

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

Fix2Lock - 08809595977320 Catalog Number :

Device Description : Biocombi Lateral Anchor '4.75' 1Line(Metabiomed)(USP#2)(White/Green)

Device Class : 2

Duns Number: 688999370

Premarket Exempt : No

Product Code : MAI, MBI

Prescription Use : Yes

Device Count : 1

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