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 - 00817580027088 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI092920-LW1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580027262 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI063020-TN1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580027354 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI070820-KT1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580027361 Catalog Number : PEEK-IM1003

Device Description : PEEK Customized Cranial Implant, LargeCSI011320-TH1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580027378 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI012320-HD1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580027385 Catalog Number : PEEK-IM1003

Device Description : PEEK Customized Cranial Implant, LargeCSI070720-HS1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580027392 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI012320-RD1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580027408 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI012220-BE1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580027415 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-Large & X-LargeCSI071020-SS1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

Kelyniam CSI - 00817580027422 Catalog Number : PEEK-IM1004

Device Description : PEEK Customized Cranial Implant, X-LargeCSI070920-JS1

Device Class : 2

Duns Number: 785088829

Premarket Exempt : No

Product Code : GXN

Prescription Use : Yes

Device Count : 1

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