FDA.reportPublic FDA data

PRO OSTEON 500R

Primary DI
00888480584902
Brand
PRO OSTEON 500R
Company
Biomet Orthopedics, LLC
Model
5RBW108
Catalog number
5RBW108
Device description
Resorbable Bone Graft Substitute Block, W-Block
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888480584902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888480584902008884805849028884805849020888480584902

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, syntheticA sterile 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 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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-348-9500customerservice@biomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024707061A.L.P.S.®2142-35-0072142350072026-05-11
00889024707078DRILL BIT2312002012312002012026-05-11
00889024707085DRILL BIT8290-29-0708290290702026-05-11
00880304410541FIBER OPTICS FOR RC RETRACTOR9085349085342019-06-11
00880304321946BIFURCATED FIBER OPTIC CABLE31-55550231-5555022017-07-28
008803044639124MM X 9FT. LIGHT CABLE9061179061172017-07-28
00889024707054CALIBRATED DRILL BIT2142-27-0702142270702026-04-27
00880304233102Biomet® Knee System1418721418722015-10-24
00880304233126Biomet® Knee System1418741418742015-10-24
00880304233140Biomet® Knee System1418761418762015-10-24
00880304233164Biomet® Knee System1418781418782015-10-24
00880304233171Biomet® Knee System1418801418802015-10-24
00880304233188Biomet® Knee System1418821418822015-10-24
00880304433403Vanguard® Knee System1841441841442015-10-24
00880304433410Vanguard® Knee System1841811841812015-10-24
00880304433564Vanguard® Knee System1842851842852015-10-24
00880304433984Vanguard® Knee System1842801842802015-10-24
00880304434356Vanguard® Knee System1842651842652015-10-24
00880304434363Vanguard® Knee System1842701842702015-10-24
00880304434370Vanguard® Knee System1842811842812015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M263W21000WizardBio Resorbable Calcium Phosphate CementDSM BIOMEDICAL, INC.MQV2019-01-02
M263W23000WizardBio Resorbable Calcium Phosphate CementDSM BIOMEDICAL, INC.MQV2019-01-02
08719699710122MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710276MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710283MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710290MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710306MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710313MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710320MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710337MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710344MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710351MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710368MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710375MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710382MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710399MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710405MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710412MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710436MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710443MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710450MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710429MagnetOsKuros Biosciences B.V.MQV2018-01-05
08809204338580TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338597TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338603TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338610TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338627TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338634TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338641TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338658TruForm+Hans Biomed Corp.MQV2017-07-18