FDA.reportPublic FDA data

OsteoSurge 100 Putty

Primary DI
M386563000101
Brand
OsteoSurge 100 Putty
Company
ISOTIS ORTHOBIOLOGICS, INC.
Model
56300010
Catalog number
56300010
Device description
OsteoSurge100, 1cc - demineralized human bone mixed with poloxamer reverse phase medium. OsteoSurge100 is formulated into a putty form and is provided
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
MBPFiller, bone void, osteoinduction (w/o human growth factor)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)Orthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061880000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061880000ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CCIsotis NV2007-08-15MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981055790PrimaryGS10
M386563000101SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998105579010889981055790

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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08809204338665TruForm+Hans Biomed Corp.MBP2017-07-18
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08809204338689TruFormHans Biomed Corp.MBP2017-07-18
08809204338696TruFormHans Biomed Corp.MBP2017-07-18
08809204338702TruFormHans Biomed Corp.MBP2017-07-18
08809204338719TruFormHans Biomed Corp.MBP2017-07-18
08809204338726TruFormHans Biomed Corp.MBP2017-07-18
08809204338733TruFormHans Biomed Corp.MBP2017-07-18
08809204338740TruFormHans Biomed Corp.MBP2017-07-18
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08809204338764TruFormHans Biomed Corp.MBP2017-07-18
08809204338771TruFormHans Biomed Corp.MBP2017-07-18
08809204338498ExponentHans Biomed Corp.MBP2017-03-09
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08809204339754TruForm+Hans Biomed Corp.MBP2016-08-26
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