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

METHYL METHACRYLATE FOR CRANIOPLASTY (GXP) (8) FILLER, BONE VOID, CALCIUM COMPOUND (MQV) (1)

Premarket Exempt

Clear

Ossilix - 00813845021075 Catalog Number : 662-01-10

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

OsteoVation - 00813845021082 Catalog Number : 390-6001

Device Description : OsteoVation RMx Injectable Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : GXP

Prescription Use : Yes

Device Count : 1

OsteoVation - 00813845021099 Catalog Number : 390-6002

Device Description : OsteoVation RMx Injectable Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : GXP

Prescription Use : Yes

Device Count : 1

CranioSculpt - 00813845021105 Catalog Number : C-C3CC

Device Description : CranioSculpt C 3cc

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : GXP

Prescription Use : Yes

Device Count : 1

CranioSculpt - 00813845021112 Catalog Number : C-C5CC

Device Description : CranioSculpt C 5cc

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : GXP

Prescription Use : Yes

Device Count : 1

CranioSculpt - 00813845021129 Catalog Number : C-C10CC

Device Description : CranioSculpt C 10cc

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : GXP

Prescription Use : Yes

Device Count : 1

OsteoMed - 00842528100172 Catalog Number : 390-6005

Device Description : OsteoVation RM-EX, 5cc

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : GXP

Prescription Use : Yes

Device Count : 1

OsteoMed - 00842528100189 Catalog Number : 390-6010

Device Description : OsteoVation RM-EX, 10cc

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : GXP

Prescription Use : Yes

Device Count : 1

OsteoMed - 00842528104156 Catalog Number : 390-6003

Device Description : OsteoVation RM-EX Inject, Bone Void Filler, 3cc

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : GXP

Prescription Use : Yes

Device Count : 1

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