SHEFABONE INC

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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

Bone Grafting Material, Synthetic (LYC) (1)

Premarket Exempt

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Shefabone™ - 05060517850005 Catalog Number : SCPC-1

Device Description : Silica-Calcium Phosphate Composite (SCPC) is a synthetic resorbable osteoconduct Silica-Calcium Phosphate Composite (SCPC) is a synthetic resorbable osteoconductive bone graft substitute composed of two phases: sodium calcium phosphate (NaCaPO4) and silica (SiO2). The two phases are sintered together in the form of solid solutions.The SCPC is in the form of porous particles in the size range 90-710 micron.The device is sterlized by Gama radiation.

Device Class : 2

Duns Number: 080521608

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

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