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510(k) Data Aggregation
K Number
K173525Device Name
NovoGro
Manufacturer
OsteoNovus, Inc.
Date Cleared
2018-04-06
(143 days)
Product Code
MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
OsteoNovus, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NovoGro Putty is an implant intended to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine and pelvis). NovoGro must be used with autograft as a bone extender in the posterolateral spine. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The device resorbs and is replaced with bone during the healing process.
Device Description
NovoGro Putty is provided to the end-user as two components (dry powder and aqueous solution) that must be mixed intra-operatively prior to implantation using the supplied mixing system to form a moldable cohesive putty-like graft. The dry powder component of NovoGro Putty contains spherical particles that are composed primarily of a co-precipitate of dicalcium phosphate anhydrite Imonetite. CaHPO4], magnesium phosphate trihydrate [newberyite, Mg(PO2OH)+3(H2O)] and sodium hydrogen phosphate [NaH2PO4]. Small amounts of silica (SiO2) and magnesium oxide (MgO) are combined with this co-precipitate during manufacturing. These spherical particles are mixed heterogeneously with dry sodium carboxymethyl cellulose (CMC) powder to enhance the handling properties of the final mixed graft. The aqueous component of NovoGro is ultrapure reverse osmosis deionized water (DI H2O). NovoGro Putty is provided sterile for single use in volumes ranging from 1 cc to 20 cc. NovoGro Putty is provided in a kit with a mixing system, a vial of ultrapure water for mixing, and a graduated syringe to measure the correct volume of the supplied ultrapure water to add to the dry component.
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K Number
K162087Device Name
NovoGro
Manufacturer
OsteoNovus, Inc.
Date Cleared
2017-04-18
(264 days)
Product Code
MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
OsteoNovus, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NovoGro Putty is intended for use as a bone void filler for gaps and voids that are not intrinsic to the stability of the bony structure. NovoGro Putty is intended to be hydrated with sterile water and gently packed into bony voids or gaps of the skeletal system, i.e., extremities and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NovoGro Putty provides a bone void filler that resorbs and is replaced by bone during the healing process.
Device Description
NovoGro Putty is provided to the end-user as two components (dry powder and aqueous solution) that must be mixed intra-operatively prior to implantation using the supplied mixing system to form a moldable cohesive putty-like graft. The dry powder component of NovoGro Putty contains spherical beads that are composed primarily of a co-precipitate of dicalcium phosphate anhydrite Imonetite. CaHPO4], magnesium phosphate trihydrate [newberyite, Mg(PO2OH)+3(H2O)] and sodium hydrogen phosphate [NaH2PO4]. Small amounts of silica (SiO2) and magnesium oxide (MgO) are combined with this co-precipitate during manufacturing. These spherical beads are mixed heterogeneously with dry sodium carboxymethyl cellulose (CMC) powder to enhance the handling properties of the final mixed graft. The aqueous component of NovoGro is ultrapure reverse osmosis deionized water (DI H2O). NovoGro Putty is provided sterile for single use in volumes ranging from 1 cc to 20 cc. NovoGro Putty is provided in a kit with a mixing system, a vial of ultrapure water for mixing, and a graduated syringe to measure the correct volume of the supplied ultrapure water to add to the dry component.
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