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) PROSTHESIS, CHIN, INTERNAL (FWP) (5)

Premarket Exempt

Clear

OsteoVation - 00813845020009 Catalog Number : 390-0002

Device Description : OsteoVation EX Inject Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

OsteoVation - 00813845020016 Catalog Number : 390-0003

Device Description : OsteoVation EX Inject Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

OsteoVation - 00813845020023 Catalog Number : 390-0005

Device Description : OsteoVation EX Inject Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

OsteoVation - 00813845020030 Catalog Number : 390-0203

Device Description : OsteoVation EX Impact Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

OsteoVation - 00813845020047 Catalog Number : 390-0205

Device Description : OsteoVation EX Impact Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

OsteoVation - 00813845020054 Catalog Number : 390-2005

Device Description : OsteoVation Inject Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : FWP, GXP

Prescription Use : Yes

Device Count : 1

OsteoVation - 00813845020061 Catalog Number : 390-2010

Device Description : OsteoVation Inject Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : FWP, GXP

Prescription Use : Yes

Device Count : 1

OsteoVation - 00813845020078 Catalog Number : 390-2103

Device Description : OsteoVation Impact Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : GXP, FWP

Prescription Use : Yes

Device Count : 1

OsteoVation - 00813845020085 Catalog Number : 390-2105

Device Description : OsteoVation Impact Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : GXP, FWP

Prescription Use : Yes

Device Count : 1

OsteoVation - 00813845020092 Catalog Number : 390-2110

Device Description : OsteoVation Impact Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : FWP, GXP

Prescription Use : Yes

Device Count : 1

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