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

Callos - 00813845020221 Catalog Number : 65-0003-S

Device Description : Callos Inject Bone Void Filler Mixing and Delivery System for Acumed

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Callos - 00813845020238 Catalog Number : 65-0005-S

Device Description : Callos Inject Bone Void Filler Mixing and Delivery System for Acumed

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Callos - 00813845020245 Catalog Number : 65-0010-S

Device Description : Callos Inject Bone Void Filler Mixing and Delivery System for Acumed

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Callos - 00813845020252 Catalog Number : 65-0105-S

Device Description : Callos Impact Bone Void Filler Mixing and Delivery System for Acumed

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Callos - 00813845020269 Catalog Number : 65-0110-S

Device Description : Callos Impact Bone Void Filler Mixing and Delivery System for Acumed

Device Class : 2

Duns Number: 140071411

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

ProModel - 00813845020276 Catalog Number : 65-1003-S

Device Description : ProModel 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

ProModel - 00813845020283 Catalog Number : 65-1005-S

Device Description : ProModel 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

ProModel - 00813845020290 Catalog Number : 65-1010-S

Device Description : ProModel 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

ProModel - 00813845020306 Catalog Number : 65-1105-S

Device Description : ProModel 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

ProModel - 00813845020313 Catalog Number : 65-1110-S

Device Description : ProModel 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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