S.B.M

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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

Fastener, Fixation, Biodegradable, Soft Tissue (MAI) (9) Filler, Bone Void, Calcium Compound (MQV) (1)

Premarket Exempt

Clear

BIOSORB - 03760154007009 Catalog Number : P822694446

Device Description : Absorbable calcium salt bone void filler

Device Class : 2

Duns Number: 772462123

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

ComposiTCP - 03760154007016 Catalog Number : 110004600

Device Description : Absorbable interference screw

Device Class : 2

Duns Number: 772462123

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

ComposiTCP - 03760154007023 Catalog Number : 110004601

Device Description : Absorbable interference screw

Device Class : 2

Duns Number: 772462123

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

ComposiTCP - 03760154007030 Catalog Number : 110004612

Device Description : Absorbable interference screw

Device Class : 2

Duns Number: 772462123

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

ComposiTCP - 03760154007047 Catalog Number : 110004603

Device Description : Absorbable interference screw

Device Class : 2

Duns Number: 772462123

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

ComposiTCP - 03760154007153 Catalog Number : 905210

Device Description : Absorbable interference screw

Device Class : 2

Duns Number: 772462123

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

ComposiTCP - 03760154007160 Catalog Number : 905211

Device Description : Absorbable interference screw

Device Class : 2

Duns Number: 772462123

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

ComposiTCP - 03760154007177 Catalog Number : 905212

Device Description : Absorbable interference screw

Device Class : 2

Duns Number: 772462123

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

ComposiTCP - 03760154007184 Catalog Number : 905213

Device Description : Absorbable interference screw

Device Class : 2

Duns Number: 772462123

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

ComposiTCP - 03760154007191 Catalog Number : 905214

Device Description : Absorbable interference screw

Device Class : 2

Duns Number: 772462123

Premarket Exempt : No

Product Code : MAI

Prescription Use : Yes

Device Count : 1

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