FDA.reportPublic FDA data

RESORBA Synthetic Bone

Primary DI
03700501813501
Brand
RESORBA Synthetic Bone
Company
BIOMATLANTE
Model
SB1002PU50DE
Catalog number
SB1002PU50DE
Device description
Injectable Bone Substitute 1G (80-200µm)Resorbable Bone GraftInjectable Bone Substitute 0.5 mL (x1)
Published
2024-05-16
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
LYCBone Grafting Material, Synthetic

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060732000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060732000MBCP GELBiomatlante2006-06-02LYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700501813501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700501813501037005018135013700501813501

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, synthetic, non-antimicrobialA 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 does not include an antimicrobial agent(s). 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Inches of Mercury30 Inches of Mercury

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
493710719
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700501813402RESORBA Synthetic BoneSB0302G01SB0302G012024-05-17
03700501813426RESORBA Synthetic BoneSB0401GS01SB0401GS012024-05-17
03700501813440RESORBA Synthetic BoneSB0701M+G50SB0701M+G502024-05-17
03700501813457RESORBA Synthetic BoneSB0701M+G01SB0701M+G012024-05-17
03700501813488RESORBA Synthetic BoneSB0701M+GS50SB0701M+GS502024-05-17
03700501813495RESORBA Synthetic BoneSB0701M+GS01SB0701M+GS012024-05-17
03700501813549RESORBA Synthetic BoneSB0702M+G02SB0702M+G022024-05-17
03700501813518RESORBA Synthetic BoneSB1001PU01DESB1001PU01DE2024-05-16
03700501814133MBCP2301G032301G032024-04-02
03700501806961IN'OSS1101PU25DE1101PU25DE2016-05-11
03700501807760MBCP1301G5501301G5502016-05-11
03700501807777MBCP1301GS5501301GS5502016-05-11
03700501807784MBCP1301G5011301G5012016-05-11
03700501810296OssGroLE1102GS05LE1102GS052017-09-21
03700501810302OssgroLE1102GS10LE1102GS102018-06-20
03700501810319OssGroLE9902G10LE9902G102017-09-22
03700501810326OssGroLE0602G30LE0602G302017-09-22
03700501810333OssGroLE0503G05LE0503G052017-09-22
03700501810340OssGroLE9903G10LE9903G102017-09-22
03700501810357OssGroLE0803G20LE0803G202017-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640164360041Gibson Healthcare AlloplastDegradable Solutions AGLYC2024-03-05
07640164360065Gibson Healthcare AlloplastDegradable Solutions AGLYC2024-03-05
08720165038077OsOpiaRevisiOs B.V.LYC2021-06-30
08809324764870OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764887OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764894OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764900OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764917OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764924OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764931OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764948OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764955OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764962OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764979OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764986OSTEONGENOSS CO., Ltd.LYC2018-07-10
08809324764993OSTEON SinusGENOSS CO., Ltd.LYC2018-07-10
08809324765006OSTEON SinusGENOSS CO., Ltd.LYC2018-07-10
08809324765013OSTEON LiftingGENOSS CO., Ltd.LYC2018-07-10
08809324765020OSTEON LiftingGENOSS CO., Ltd.LYC2018-07-10
08809324765082OSTEON ll SinusGENOSS CO., Ltd.LYC2018-07-10
08809324765105OSTEON ll SinusGENOSS CO., Ltd.LYC2018-07-10
08809324765136OSTEON ll LiftingGENOSS CO., Ltd.LYC2018-07-10
08809324765174OSTEON ll LiftingGENOSS CO., Ltd.LYC2018-07-10
08809324768014OsteonIIIGENOSS CO., Ltd.LYC2018-07-10
08809324768021OsteonIIIGENOSS CO., Ltd.LYC2018-07-10
08809324768038OsteonIIIGENOSS CO., Ltd.LYC2018-07-10
08809324768045OsteonIIIGENOSS CO., Ltd.LYC2018-07-10
08809324768052OsteonIIIGENOSS CO., Ltd.LYC2018-07-10
08809324768069OsteonIIIGENOSS CO., Ltd.LYC2018-07-10
08809324768076OsteonIIIGENOSS CO., Ltd.LYC2018-07-10