SKELETAL KINETICS LLC

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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

FILLER, BONE VOID, CALCIUM COMPOUND (MQV) (5) METHYL METHACRYLATE FOR CRANIOPLASTY (GXP) (5)

Premarket Exempt

Clear

Callos - 00813845020634 Catalog Number : CALL-JE05

Device Description : Callos Inject Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Callos - 00813845020641 Catalog Number : CALL-JE10

Device Description : Callos Inject Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Callos - 00813845020658 Catalog Number : CALL-PA05

Device Description : Callos Impact Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Callos - 00813845020665 Catalog Number : CALL-PA10

Device Description : Callos Impact Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Callos - 00813845020672 Catalog Number : CALL-PA25

Device Description : Callos Impact Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

SKaffold - 00813845020689 Catalog Number : CMMP-IM05

Device Description : SKaffold CMF Impress Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : GXP

Prescription Use : Yes

Device Count : 1

SKaffold - 00813845020696 Catalog Number : CMMP-IM10

Device Description : SKaffold CMF Impress Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : GXP

Prescription Use : Yes

Device Count : 1

SKaffold - 00813845020702 Catalog Number : CMMX-FL05

Device Description : SKaffold CMF Flow Bone Void Filler Mixing and Delivery System

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : GXP

Prescription Use : Yes

Device Count : 1

SKaffold - 00813845020719 Catalog Number : CMMX-FL10

Device Description : SKaffold CMF Flow Bone Void Filler Mixing and Delivery System

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : GXP

Prescription Use : Yes

Device Count : 1

SKaffold - 00813845020726 Catalog Number : CMMX-IM05

Device Description : SKaffold CMF Impress Bone Void Filler Mixing and Delivery System

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : GXP

Prescription Use : Yes

Device Count : 1

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