IsoTis Mozaik Moldable Morsels

Primary DI
10889981056032
Brand
IsoTis Mozaik Moldable Morsels
Company
ISOTIS ORTHOBIOLOGICS, INC.
Model
MSL015
Catalog number
MSL015
Device description
IsoTis Mozaik™ Moldable Morsels Mini, 1.5cc - 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
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

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
10889981056032PrimaryGS10
M269MSL0151SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998105603210889981056032

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone void filling material, synthetic/animal-derivedA bioabsorbable, implantable device made of synthetic materials (e.g., ceramics such as tricalcium phosphate or hydroxyapatite) combined with animal-derived bone growth factors (e.g., bovine collagen) 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 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 Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
801089152
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
10889981055394Accell Evo3 Putty02-5000-02502-5000-0252015-09-24
10889981055400Accell Evo3 Putty02-5000-05002-5000-0502015-09-24
10889981055417Accell Evo3 Putty02-5000-10002-5000-1002015-09-24
10889981055424Accell Evo3 C Putty02-6000-02502-6000-0252015-09-24
10889981055431Accell Evo3 C Putty02-6000-05002-6000-0502015-09-24
10889981055448Accell Evo3 C Putty02-6000-10002-6000-1002015-09-24
10889981055455Accell Connexus02-3000-00502-3000-0052015-09-24
10889981055462Accell Connexus02-3000-01002-3000-0102015-09-24
10889981055479Accell Connexus02-3000-02502-3000-0252015-09-24
10889981055486Accell Connexus02-3000-05002-3000-0502015-09-24
10889981055493Accell Connexus02-3000-10002-3000-1002015-09-24
10889981055509Dynagraft II Gel02-2000-00502-2000-0052015-09-24
10889981055516Dynagraft II Gel02-2000-01002-2000-0102015-09-24
10889981055523Dynagraft II Gel02-2000-05002-2000-0502015-09-24
10889981055530Dynagraft II Gel02-2000-10002-2000-1002015-09-24
10889981055547Dynagraft II Putty02-2010-01002-2010-0102015-09-24
10889981055554Dynagraft II Putty02-2010-02502-2010-0252015-09-24
10889981055561Dynagraft II Putty02-2010-05002-2010-0502015-09-24
10889981055578Dynagraft II Putty02-2010-10002-2010-1002015-09-24
10889981055585Orthoblast II Paste02-2100-00502-2100-0052015-09-24

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