FDA.reportPublic FDA data

IsoTis Mozaik Moldable Morsels

Primary DI
10889981056056
Brand
IsoTis Mozaik Moldable Morsels
Company
ISOTIS ORTHOBIOLOGICS, INC.
Model
MSL075
Catalog number
MSL075
Device description
IsoTis Mozaik™ Moldable Morsels Max, 7.5cc - A resorbable bone void filler made from microfibrillar collagen combined with tricalcium phosphate (TCP) granules and cubes.
Published
2015-09-24
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091302000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091302000INTEGRA MOZAIK AND OS MOLDABLE MORSELSIntegra LifeSciences Corporation2009-12-04MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981056056PrimaryGS10
M269MSL0751SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998105605610889981056056

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, compositeA sterile bioabsorbable device made of synthetic bone substitute materials (e.g., ceramics such as tricalcium phosphate or hydroxyapatite) combined with bone growth factors (e.g., bovine collagen) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)550-7155Irvine.customerservice@seaspine.com

Regulatory Flags#

DUNS number
801089152
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889981232122Ballast02-1000-00002-1000-0002020-07-30
10889981232139Ballast02-1100-00002-1100-0002020-07-30
10889981232146OsteoBallast56100000561000002020-07-30
10889981232153OsteoBallast56110000561100002020-07-30
10889981055899IsoTis Mozaik PuttyPTY10125PTY101252015-09-24
10889981055905IsoTis Mozaik PuttyPTY10155PTY101552015-09-24
10889981055912IsoTis Mozaik PuttyPTY10210PTY102102015-09-24
10889981055929IsoTis Mozaik PuttyPTY10256PTY102562015-09-24
10889981055943IsoTis Mozaik StripCCM10210CCM102102015-09-24
10889981055950IsoTis Mozaik StripCCM10256CCM102562015-09-24
10889981180461Current02-9000-01002-9000-0102019-10-28
10889981180478Current02-9000-02502-9000-0252019-10-28
10889981180485Current02-9000-05002-9000-0502019-10-28
10889981180492Current02-9000-10002-9000-1002019-10-28
10889981180508OsteoCurrent56900010569000102019-10-28
10889981180515OsteoCurrent56900025569000252019-10-28
10889981180522OsteoCurrent56900050569000502019-10-28
10889981180539OsteoCurrent56900100569001002019-10-28
10889981055394Accell Evo3 Putty02-5000-02502-5000-0252015-09-24
10889981055400Accell Evo3 Putty02-5000-05002-5000-0502015-09-24

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Primary DI, Brand, Company table
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ECUR9920302VerteFramecurasan AGMQV2026-06-25
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ECUR9920310VerteFramecurasan AGMQV2026-06-25
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ECURCCLF25250CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLF2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2512CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2525CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURTFF1050TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFF1100TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFM1050TriForm Moldable Foamcurasan AGMQV2026-06-25
ECURTFM1100TriForm Moldable Foamcurasan AGMQV2026-06-25
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W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.MQV2026-06-05
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