FDA.reportPublic FDA data

ENDOBON®

Primary DI
03599870097564
Brand
ENDOBON®
Company
ZimVie US Corp LLC
Model
ROXLG20
Device description
ENDOBON® XENOGRAFT GRANULES LARGE PARTICLE 2.0ML
Published
2015-09-10
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
LYCBone grafting material, synthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYCBone Grafting Material, SyntheticDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03599870097564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03599870097564035998700975643599870097564

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone void filling material, animal-derived, non-bioabsorbableA non-bioabsorbable, implantable device made primarily of animal-derived materials (e.g., heat-treated hydroxyapatite ceramic from animal cancellous bone) intended to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it is not dedicated to dental applications. Also referred to as a graft, matrix, or void filler, it typically provides an osteoconductive scaffold that promotes bone growth, and is used to fill bone cavities, defects, and fractures. It is typically provided as cancellous blocks, cylinders, or granules.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Total Volume0

Contacts#

Phone, Email table
PhoneEmail
+1(800)342-54543iPBG-CS@biomet.com

Regulatory Flags#

DUNS number
119287313
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
03599870091258ENDOBON®ROX052015-09-10
03599870091265ENDOBON®ROX102015-09-10
03599870091272ENDOBON®ROX202015-09-10
03599870097571ENDOBON®ROXLG502015-09-10
03599870097588ENDOBON®ROXLG802015-09-10
00844868036098BIOGRAN®2100-00032015-08-31
00844868036104BIOGRAN®2100-00042015-08-31
00844868036111BIOGRAN®2100-00052015-08-31
00844868052463T3® ProDEPTHGTRAYN/A2026-05-28
00844868052470T3® PROEXHEXTOOLTRAY2026-05-28
00844868052487T3® PROOPENWRENCHTRAYN/A2026-05-28
00844868052494T3® PROT3PDRILLTRAYN/A2026-05-28
00844868052500T3® PROT3PLIDBASE2026-05-28
00844868052517T3® PROT3PTAPTRAY342026-05-28
00844868052524T3® PROT3PTAPTRAY56N/A2026-05-28
00844868052531T3® PROT3PTOOLTRAYN/A2026-05-28
00844868052548T3® ShortT3SHORTTRAYN/A2026-05-28
00844868052814Terrats Competitive Connection AbutmentsMALDAGU2026-05-18
00844868052821Terrats Competitive Connection AbutmentsNALDAG352026-05-18
00844868052838Terrats Competitive Connection AbutmentsNBLDAG512026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813954028798Dyna-Bone PlugCOLLAGEN MATRIX, INC.LYC2026-07-02
00813954028804Dyna-Bone PlugCOLLAGEN MATRIX, INC.LYC2026-07-02
03700501800440MBCP+®BIOMATLANTELYC2026-06-29
03700501800457MBCP+®BIOMATLANTELYC2026-06-29
03700501800464MBCP+®BIOMATLANTELYC2026-06-29
03700501800471MBCP+®BIOMATLANTELYC2026-06-29
03700501800488MBCP+®BIOMATLANTELYC2026-06-29
03700501800495MBCP+®BIOMATLANTELYC2026-06-29
03700501800693MBCP+®BIOMATLANTELYC2026-06-29
03700501800709MBCP+®BIOMATLANTELYC2026-06-29
03700501800716MBCP+®BIOMATLANTELYC2026-06-29
00813954028767Gibson Healthcare AlloplastCOLLAGEN MATRIX, INC.LYC2026-05-26
00813954028774Gibson Healthcare AlloplastCOLLAGEN MATRIX, INC.LYC2026-05-26
00813954028781Gibson Healthcare AlloplastCOLLAGEN MATRIX, INC.LYC2026-05-26
00813954026787SynOss PlugCOLLAGEN MATRIX, INC.LYC2025-09-05
00813954026794SynOss PlugCOLLAGEN MATRIX, INC.LYC2025-09-05
00813909010335Dental Porous Morsels 2x1.5gNOVABONE PRODUCTS, LLCLYC2025-07-17
00813909010328Dental Porous Morsels 2x0.5gNOVABONE PRODUCTS, LLCLYC2025-07-17
00813954027128PLENA PLUGCOLLAGEN MATRIX, INC.LYC2025-07-16
00813954027135PLENA PLUGCOLLAGEN MATRIX, INC.LYC2025-07-16
00813954027050TBS Bone PlugCOLLAGEN MATRIX, INC.LYC2025-05-19
00813954027067TBS Bone PlugCOLLAGEN MATRIX, INC.LYC2025-05-19
00813954027074TBS Bone PlugCOLLAGEN MATRIX, INC.LYC2025-05-19
00813954027081TBS Bone PlugCOLLAGEN MATRIX, INC.LYC2025-05-19
00813909013367Dental Putty Cartridge 2 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013374Dental Putty Cartridge 6 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013473PerioGlas - 2 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013480PerioGlas 6 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013503Dental Putty - 6 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013510Dental Putty Cartridge 4 x 0.25ccNOVABONE PRODUCTS, LLCLYC2025-04-25