KELYNIAM GLOBAL, INC.

Address:97 RIVER RD STE A,COLLINSVILLE,CT,06019,US

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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

Plate, Cranioplasty, Preformed, Non-Alterable (GXN) (10)

Premarket Exempt

Clear

Kelyniam CSI - 00817580027552 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI070920-JD1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580028481 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI021420-AB1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580028498 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI020320-JL1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580028504 Catalog Number : PEEK-IM1001

Device Description : PEEK Customized Cranial Implant, SmallCSI033120-GE1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580028511 Catalog Number : PEEK-IM1002

Device Description : PEEK Customized Cranial Implant, MediumCSI011320-ME1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580028528 Catalog Number : PEEK-IM1002

Device Description : PEEK Customized Cranial Implant, MediumCSI012520-DM1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580028535 Catalog Number : PEEK-IM1002

Device Description : PEEK Customized Cranial Implant, MediumCSI012820-JB1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580028542 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI012120-CP1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580028559 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI022720-KK1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580028566 Catalog Number : PEEK-IM1002

Device Description : PEEK Customized Cranial Implant, MediumCSI041620-AF1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

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