FDA.reportPublic FDA data

OsteoSparx C Putty

Primary DI
M386562300501
Brand
OsteoSparx C Putty
Company
ISOTIS ORTHOBIOLOGICS, INC.
Model
56230050
Catalog number
56230050
Device description
OsteoSparx C Putty, 5cc - derived from selected donated human bone tissue that has been processed into particles. The particles are subsequently demin
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
K050642000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050642000ORTHOBLAST II PUTTY AND PASTEIsotis Orthobiologics, Inc.2005-12-05MBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981055776PrimaryGS10
M386562300501SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998105577610889981055776

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199284455788BonVie+ELUTE , INC.MQV2025-08-13
00643169964938GRAFTON™ DBMMEDTRONIC SOFAMOR DANEK, INC.MQV2024-12-05
00763000140502PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00763000140519PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00763000140526PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00763000140533PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2021-03-12
00085412630731ALTAPOREApatech LtdMQV2020-11-05
00085412678146ALTAPOREApatech LtdMQV2020-11-05
00813954023915OssiMend Bioactive MoldableCOLLAGEN MATRIX, INC.MQV2020-09-15
00085412654362ALTAPOREApatech LtdMQV2019-12-11
00085412654379ALTAPOREApatech LtdMQV2019-12-11
00085412654386ALTAPOREApatech LtdMQV2019-12-11
00085412654393ALTAPOREApatech LtdMQV2019-12-11
00813954022901OssiMend Bioactive MoldableCOLLAGEN MATRIX, INC.MQV2019-08-22
00813954022918OssiMend Bioactive MoldableCOLLAGEN MATRIX, INC.MQV2019-08-22
00813954022925OssiMend Bioactive MoldableCOLLAGEN MATRIX, INC.MQV2019-08-22
00813954022932OssiMend Bioactive MoldableCOLLAGEN MATRIX, INC.MQV2019-08-22
00813954022949OssiMend Bioactive MoldableCOLLAGEN MATRIX, INC.MQV2019-08-22
00813954022956OssiMend Bioactive MoldableCOLLAGEN MATRIX, INC.MQV2019-08-22
00813954022963OssiMend Bioactive MoldableCOLLAGEN MATRIX, INC.MQV2019-08-22
00813954022970OssiMend Bioactive MoldableCOLLAGEN MATRIX, INC.MQV2019-08-22
00613994247612PROGENIX® PUTTY and PROGENIX® PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2019-03-29
00643169965089GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.MQV2019-02-07
00613994512758MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512765MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512772MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512789MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512796MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512802MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512819MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18