FDA.reportPublic FDA data

OsteoSparx Gel

Primary DI
M386562001001
Brand
OsteoSparx Gel
Company
ISOTIS ORTHOBIOLOGICS, INC.
Model
56200100
Catalog number
56200100
Device description
OsteoSparx Gel, 10cc - derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently dem
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

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
K040419000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040419000DYNAGRAFT IIIsotis Orthobiologics, Inc.2005-03-25MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981055691PrimaryGS10
M386562001001SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998105569110889981055691

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, human-derivedAn sterile implantable device made primarily of human demineralized bone matrix (DBM) (acid extraction of allogeneic bone resulting in loss of most of the mineralized component but retention of proteins) intended to fill bony voids or gaps caused by trauma or surgery, including use in the maxillofacial and/or mandibular bone. The device is bioabsorbable, osteoconductive, and has demonstrated at least potential osteoinductivity for the stimulation of new bone growth. The DBM may be combined with various carrier compounds (e.g., gelatin, hydrogel, starch) or other materials. It is available in the form of powder, crushed granules, putty, chips, or a gel that can be injected through a syringe.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)550-7155irvine.customerservice@seaspin

Regulatory Flags#

DUNS number
801089152
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
true
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
Primary DIBrandCompanyProduct codePublished
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ECUR9920302VerteFramecurasan AGMQV2026-06-25
ECUR9920305VerteFramecurasan AGMQV2026-06-25
ECUR9920310VerteFramecurasan AGMQV2026-06-25
ECURCCLF25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
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
00849777014052Union DBM, 1ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014069Union DBM, 2.5ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014076Union DBM, 5ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014083Union DBM, 10ccXtant Medical Holdings, Inc.MQV2026-06-24
06429810349293Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349316Adaptos®FuseBiomendex OyMQV2026-06-24
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W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.MQV2026-06-05
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