FDA.reportPublic FDA data

NuROs Bone Graft Substitute(Sterile)

Primary DI
04716329941141
Brand
NuROs Bone Graft Substitute(Sterile)
Company
ORIENTAL RESOURCES DEVELOPMENT LIMITED BIOMEDICAL FACTORY
Model
BGD50
Device description
NuROs Absorbable Bone Graft Substitute is an implant intended to fill bony voids or gaps of the skeletal system, i.e., extremities and pelvis. These osseous defects aresurgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. NuROs Absorbable Bone Graft Substitute is absorbed around 6 months and replaced with bone during the healing process.
Published
2019-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140913000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140913000NUROS BONE GRAFT SUBSTITUTEOriental Resources Development Limited2015-02-17MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04716329941141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04716329941141047163299411414716329941141

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic bone graftAn artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3Millimeter
Total Volume2.5Milliliter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658871135
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04716329941400NuROs Bone Graft Substitute(Sterile)NBP502019-05-20

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ECURTFM1100TriForm Moldable Foamcurasan AGMQV2026-06-25
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W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.MQV2026-06-05
07610221017829Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01