SKELETAL KINETICS LLC

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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) (8) METHYL METHACRYLATE FOR CRANIOPLASTY (GXP) (2)

Premarket Exempt

Clear

CranioSculpt - 00813845020955 Catalog Number : C-CMF10CC

Device Description : CranioSculpt CMF Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : GXP

Prescription Use : Yes

Device Count : 1

CranioSculpt - 00813845020962 Catalog Number : C-CMF25CC

Device Description : CranioSculpt CMF Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : GXP

Prescription Use : Yes

Device Count : 1

BioWrist - 00813845020979 Catalog Number : BW01-RN05

Device Description : BioWrist Procedure Kit

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Ossilix - 00813845021006 Catalog Number : 660-02-05

Device Description : Ossilix fil 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

Ossilix - 00813845021013 Catalog Number : 660-02-10

Device Description : Ossilix fil 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

Ossilix - 00813845021020 Catalog Number : 660-01-05

Device Description : Ossilix form 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

Ossilix - 00813845021037 Catalog Number : 660-01-10

Device Description : Ossilix form 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

Ossilix - 00813845021044 Catalog Number : 662-02-05

Device Description : Ossilix MP fil 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

Ossilix - 00813845021051 Catalog Number : 662-02-10

Device Description : Ossilix MP fil 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

Ossilix - 00813845021068 Catalog Number : 662-01-05

Device Description : Ossilix MP form 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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