FDA.reportPublic FDA data

VitoMatrix

Primary DI
00808232001297
Brand
VitoMatrix
Company
Stryker Corporation
Model
2102-0401
Catalog number
2102-0401
Device description
Bone Grafting Material, Vial, Beta-Tricalcium Phosphate
Published
2015-09-24
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
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
00808232001297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00808232001297008082320012978082320012970808232001297

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(610)640-1775inst.stryker.cs@stryker.com

Regulatory Flags#

DUNS number
149183167
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
07613327687637N/A65170400166517-040-0162026-03-19
07613327687644N/A65170400106517-040-0102026-03-19
07613327687651N/A65170700216517-070-0212026-03-19
07613327687668N/A65170480216517-048-0212026-03-19
07613327687675N/A65170400126517-040-0122026-03-19
07613327628357RPS88080000008808-000-0002025-10-01
07613327656763BPX79000120007900-012-0002026-03-04
07613327656770BPX79000130007900-013-0002026-03-04
07613327657760BPX79000340007900-034-0002026-03-04
07613327657777BPX79000150007900-015-0002026-03-04
07613327657784BPX79000310007900-031-0002026-03-04
07613327657791BPX79000990007900-099-0002026-03-04
07613327657807N/A79003760107900-376-0102026-03-04
07613327657814BPX79000370007900-037-0002026-03-04
07613327657821N/A79003770107900-377-0102026-03-04
07613327657838N/A79003780107900-378-0102026-03-04
07613327659429BPX79000250007900-025-0002026-03-04
37613327693288Malis6760-180-0106760-180-010-Z012026-02-25
37613327693295Malis6760-180-0056760-180-005-Z012026-02-25
37613327693363Malis6760-180-0156760-180-015-Z012026-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813954028767Gibson Healthcare AlloplastCOLLAGEN MATRIX, INC.LYC2026-05-26
00813954028774Gibson Healthcare AlloplastCOLLAGEN MATRIX, INC.LYC2026-05-26
00813954028781Gibson Healthcare AlloplastCOLLAGEN MATRIX, INC.LYC2026-05-26
00813954028873PuraKOTE+COLLAGEN MATRIX, INC.LYC2026-05-26
00813954028897PuraTAPE+COLLAGEN MATRIX, INC.LYC2026-05-26
10813954028542bioSTRIPCOLLAGEN MATRIX, INC.LYC2026-03-09
10813954028566bioKOTECOLLAGEN MATRIX, INC.LYC2026-03-09
14550565002269Cytrans GranulesGc America Inc.LYC2026-03-03
14550565002276Cytrans GranulesGc America Inc.LYC2026-03-03
D047014615Cytrans GranulesGc America Inc.LYC2026-03-03
D047014616Cytrans GranulesGc America Inc.LYC2026-03-03
07290014838116Bond ApatiteAUGMA BIOMATERIALS LTDLYC2026-02-04
07290014838123Bond ApatiteAUGMA BIOMATERIALS LTDLYC2026-02-04
072900148381783D Bond+AUGMA BIOMATERIALS LTDLYC2026-02-04
072900148381853D Bond+AUGMA BIOMATERIALS LTDLYC2026-02-04
072900148381923D Bond+AUGMA BIOMATERIALS LTDLYC2026-02-04
072900148382083D BondAUGMA BIOMATERIALS LTDLYC2026-02-04
072900148382153D BondAUGMA BIOMATERIALS LTDLYC2026-02-04
07290014838130Bond ApatiteAUGMA BIOMATERIALS LTDLYC2026-01-15
00813954028392SynOssCOLLAGEN MATRIX, INC.LYC2026-01-06
00813954028408SynOssCOLLAGEN MATRIX, INC.LYC2026-01-06
00813954028415SynOssCOLLAGEN MATRIX, INC.LYC2026-01-06
00813954028422SynOssCOLLAGEN MATRIX, INC.LYC2026-01-06
00813909010328Dental Porous Morsels 2x0.5gNOVABONE PRODUCTS, LLCLYC2025-07-17
00813909013756Dental Porous Morsels 2x1.5gNOVABONE PRODUCTS, LLCLYC2025-07-17
00813954027081TBS Bone PlugCOLLAGEN MATRIX, INC.LYC2025-05-19
00813909013329Dental Putty Syringe 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013336Dental Putty Syringe 1.0ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013343Dental Putty Syringe 2.0ccNOVABONE PRODUCTS, LLCLYC2025-04-25
00813909013558Dental Putty Cartridge 2 x 0.5ccNOVABONE PRODUCTS, LLCLYC2025-04-25