Bone Support AB

Address:SCHEELEVAGEN 19,LUND Skane,SE

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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) (3) Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside (QRR) (1)

Premarket Exempt

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CERAMENT™BONE VOID FILLER - 07350055430035 Catalog Number : A0210-08

Device Class : 2

Duns Number: 350066052

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

CERAMENT™BONE VOID FILLER - 07350055430042 Catalog Number : A0210-09

Device Class : 2

Duns Number: 350066052

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

CERAMENT™BONE VOID FILLER - 07350055430066 Catalog Number : A0210-11

Device Class : 2

Duns Number: 350066052

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

CERAMENT® G - 07350055430387 Catalog Number :

Device Description : CERAMENT G is an implantable bone void filler (device/ drug combination product) CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for use as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) where there is a need for supplemental bone graft. CERAMENT G combines gentamicin sulfate with a bone void filler, consisting of hydroxyapatite and calcium sulfate. By eluting gentamicin, CERAMENT G can reduce the recurrence of chronic osteomyelitis from gentamicin-sensitive microorganisms in order to protect bone healing. By combining calcium sulfate and hydroxyapatite, a balance is achieved between implant resorption rate and bone remodeling rate. Calcium sulfate acts as a resorbable carrier for hydroxyapatite. Hydroxyapatite has a slow resorption rate and high osteoconductivity providing a scaffold for new bone generation. The use of CERAMENT G eliminates the need to harvest autologous bone, thereby avoiding donor site morbidity (e.g., pain, infection, etc.) in patients with a diagnosed infection. CERAMENT G may be implanted by an injectable system or inserted as pre-set beads.

Device Class : 2

Duns Number: 350066052

Premarket Exempt : No

Product Code : QRR

Prescription Use : Yes

Device Count : 1

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