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) (9) METHYL METHACRYLATE FOR CRANIOPLASTY (GXP) (1)

Premarket Exempt

Clear

SKaffold - 00813845020733 Catalog Number : CMMX-IM10

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

SKaffold - 00813845020764 Catalog Number : SKAF-FL05

Device Description : SKaffold Flow Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

SKaffold - 00813845020771 Catalog Number : SKAF-FL10

Device Description : SKaffold Flow Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

SKaffold - 00813845020788 Catalog Number : SKAF-IM05

Device Description : SKaffold Impress Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

SKaffold - 00813845020795 Catalog Number : SKAF-IM10

Device Description : SKaffold Impress Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

SKaffold - 00813845020801 Catalog Number : SKAF-IM25

Device Description : SKaffold Impress Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Induce - 00813845020818 Catalog Number : SKIN-BD06

Device Description : Induce Beads Beta TCP Kint

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Induce - 00813845020825 Catalog Number : SKIN-BD12

Device Description : Induce Beads Beta TCP Kint

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

SKaffold ReNu - 00813845020832 Catalog Number : SKMA-FL03

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

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

SKaffold ReNu - 00813845020849 Catalog Number : SKMA-FL05

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

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

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