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) (2)

Premarket Exempt

Clear

CranioSculpt - 00813845020429 Catalog Number : C-FORM5CC

Device Description : CranioSculpt Form Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : GXP

Prescription Use : Yes

Device Count : 1

CranioSculpt - 00813845020436 Catalog Number : C-FORM5CC-CAN

Device Description : CranioSculpt Form Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : GXP

Prescription Use : Yes

Device Count : 1

CranioSculpt - 00813845020443 Catalog Number : C-FORM5CC-OUS

Device Description : CranioSculpt Form Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : GXP

Prescription Use : Yes

Device Count : 1

CranioSculpt - 00813845020450 Catalog Number : C-FORM10CC

Device Description : CranioSculpt Form Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : GXP

Prescription Use : Yes

Device Count : 1

CranioSculpt - 00813845020467 Catalog Number : C-FORM10CC-CAN

Device Description : CranioSculpt Form Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : GXP

Prescription Use : Yes

Device Count : 1

CranioSculpt - 00813845020474 Catalog Number : C-FORM10CC-OUS

Device Description : CranioSculpt Form Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : GXP

Prescription Use : Yes

Device Count : 1

CranioSculpt - 00813845020481 Catalog Number : C-FORM25CC

Device Description : CranioSculpt Form Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : GXP

Prescription Use : Yes

Device Count : 1

CranioSculpt - 00813845020498 Catalog Number : C-FORM25CC-CAN

Device Description : CranioSculpt Form Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : GXP

Prescription Use : Yes

Device Count : 1

Medtronic - 00813845020504 Catalog Number : C07A

Device Description : Medtronic Bone Void Filler Small

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Medtronic - 00813845020511 Catalog Number : C07B

Device Description : Medtronic Bone Void Filler Large

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

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