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) (10)

Premarket Exempt

Clear

BONEXT - 00813845020528 Catalog Number : M-BNFL05-MX

Device Description : BONEXT Flow Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

BONEXT - 00813845020535 Catalog Number : M-BNFL10-MX

Device Description : BONEXT Flow Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

BONEXT - 00813845020542 Catalog Number : M-BNIM05-MX

Device Description : BONEXT Impress Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

BONEXT - 00813845020559 Catalog Number : M-BNIM10-MX

Device Description : BONEXT Impress Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

BONEXT - 00813845020566 Catalog Number : M-BNIM25-MP

Device Description : BONEXT Impress Bone Void Filler

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Callos - 00813845020580 Catalog Number : CALL-0003

Device Description : Callos Inject 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

Callos - 00813845020597 Catalog Number : CALL-0005

Device Description : Callos Inject 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

Callos - 00813845020603 Catalog Number : CALL-0010

Device Description : Callos Inject 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

Callos - 00813845020610 Catalog Number : CALL-0105

Device Description : Callos Impact 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

Callos - 00813845020627 Catalog Number : CALL-0110

Device Description : Callos Impact 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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