FDA.reportPublic FDA data

PRO OSTEON 500R

Primary DI
00888480584872
Brand
PRO OSTEON 500R
Company
Biomet Orthopedics, LLC
Model
5RBW079
Catalog number
5RBW079
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
OTC
false
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
00888480584872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888480584872008884805848728884805848720888480584872

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
DM exempt
false
Premarket exempt
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024706828Mini Baseplate Sizer Cannulated HandleSSI008562SSI0085622026-03-19
00889024706835Mini Baseplate Sizer 0 degree On-axis HandleSSI008561SSI0085612026-03-19
00887868551611StageOne Select4311904311902026-03-17
00887868551628StageOne Select4311914311912026-03-17
00887868551635StageOne Select4311924311922026-03-17
00887868551642StageOne Select4311934311932026-03-17
00887868551659StageOne Select4311944311942026-03-17
00887868551666StageOne Select4311954311952026-03-17
00887868551673StageOne Select4311964311962026-03-17
00887868551680StageOne Select4311974311972026-03-17
00887868551697StageOne Select4311984311982026-03-17
00887868551703STAGEONE SELECT4311994311992026-03-17
00889024706774Biomet®32-34169232-3416922026-03-12
00889024706781Biomet®32-14815332-1481532026-03-12
00889024706798Biomet®32-14815132-1481512026-03-12
00889024706804Biomet®32-34169732-3416972026-03-12
00889024706811Biomet®32-14814932-1481492026-03-12
00889024706484Vanguard®32-34702132-3470212026-02-27
00880304009615BMP CABLE CUTTER4980104980102020-05-23
00880304387676OPEN END CUTTER4980234980232020-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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