FDA.report

OsteoPro

Primary DI
00850063977074
Brand
OsteoPro
Company
OSTEONOVUS, INC.
Model
DM-OPR05
Device description
OsteoPro is intended to be hydrated with ultra-pure water and gently packed into bony voids or gaps of the skeletal system.
Published
2025-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications

CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850063977074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850063977074008500639770748500639770740850063977074

GMDN Terms

TermDefinition
Bone matrix implant, synthetic, non-antimicrobialA bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
419-530-5940customerservice@osteonovus.com

Regulatory Flags

DUNS number
079788180
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850063977081NovoGro PuttyNANGC052025-03-25
00850063977098NovoGro PuttyNANGC0252025-03-25
00850063977104NovoGro PuttyNANGC102025-03-25
00850063977111NovoGro PuttyNANGC05X2025-03-25
00850063977128NovoGro PuttyNANGC025X2025-03-25
00850063977135NovoGro PuttyNANGC10X2025-03-25
00850063977012RevoGro PuttyRGC052024-04-25
00850063977029RevoGro PuttyRGC102024-04-25
00850063977036RevoGro PuttyRGC05X2024-04-25
00850063977043RevoGro PuttyRGC025X2024-04-25
00850063977050RevoGro PuttyRGC10X2024-04-25
00850063977005RevoGro PuttyRGC0252024-04-24
00863787000430NovoGro PuttyNGC152021-10-28
00863787000478NovoGro PuttyNGC10X2020-12-11
00863787000454NovoGro PuttyNGC025X2018-06-14
00863787000461NovoGro PuttyNGC05X2018-06-14
00863787000409NovoGro PuttyNGC0252017-11-06
00863787000416NovoGro PuttyNGC052017-11-06
00863787000423NovoGro PuttyNGC102017-11-06

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810131881429OsteoFlo HydroFiber - 1cc LabeledSURGENTEC, LLCMQV2026-03-09
00810131881436OsteoFlo HydroFiber - 3cc LabeledSURGENTEC, LLCMQV2026-03-09
00810131881443OsteoFlo HydroFiber - 6cc LabeledSURGENTEC, LLCMQV2026-03-09
00810131881450OsteoFlo HydroFiber - 12cc LabeledSURGENTEC, LLCMQV2026-03-09
00810131882013Synthetic Fiber Graft - 1ccSURGENTEC, LLCMQV2026-03-09
00810131882020Synthetic Fiber Graft - 3ccSURGENTEC, LLCMQV2026-03-09
00810131882037Synthetic Fiber Graft - 6ccSURGENTEC, LLCMQV2026-03-09
00810131882044Synthetic Fiber Graft - 12ccSURGENTEC, LLCMQV2026-03-09
00810131882136Synthetic Fiber Kit - 1ccSURGENTEC, LLCMQV2026-03-09
00810131882143Synthetic Fiber Kit - 3ccSURGENTEC, LLCMQV2026-03-09
00810131882150Synthetic Fiber Kit - 6ccSURGENTEC, LLCMQV2026-03-09
00810131882167Synthetic Fiber Kit - 12ccSURGENTEC, LLCMQV2026-03-09
00810131883751OsteoFlo Fiber Graft - 1ccSURGENTEC, LLCMQV2026-03-09
00810131883768OsteoFlo Fiber Graft - 3ccSURGENTEC, LLCMQV2026-03-09
00810131883775OsteoFlo Fiber Graft - 6ccSURGENTEC, LLCMQV2026-03-09
00810131883782OsteoFlo Fiber Graft - 12ccSURGENTEC, LLCMQV2026-03-09
00813909013985Putty Syringe with Cannula 2.5ccNOVABONE PRODUCTS, LLCMQV2026-01-28
00813909013992Putty Syringe with Cannula 5.0ccNOVABONE PRODUCTS, LLCMQV2026-01-28
00813909014005Putty Syringe with Cannula 10.0ccNOVABONE PRODUCTS, LLCMQV2026-01-28
00813909013961Putty Syringe 2.5ccNOVABONE PRODUCTS, LLCMQV2026-01-09
00813909013978Putty Syringe 5.0ccNOVABONE PRODUCTS, LLCMQV2026-01-09
00850009685346Backpack AFVentris MedicalMQV2026-01-02
00850009685353Backpack AFVentris MedicalMQV2026-01-02
00813909013909Putty 2.5ccNOVABONE PRODUCTS, LLCMQV2025-12-26
00813909013916Putty 5.0ccNOVABONE PRODUCTS, LLCMQV2025-12-26
00813909013923Porous Morsels 1-2mm 5.0ccNOVABONE PRODUCTS, LLCMQV2025-12-26
00813909013930Porous Morsels 1-2mm 10.0ccNOVABONE PRODUCTS, LLCMQV2025-12-26
00813909013947Putty Syringe 2.5ccNOVABONE PRODUCTS, LLCMQV2025-12-26
00813909013954Putty Syringe 5.0ccNOVABONE PRODUCTS, LLCMQV2025-12-26
05060548020620InteliGraft™BIOSTONE CO. LIMITEDMQV2025-12-10