FDA.reportPublic FDA data

Accell TBM

Primary DI
M3860240005201
Brand
Accell TBM
Company
ISOTIS ORTHOBIOLOGICS, INC.
Model
02-4000-520
Catalog number
02-4000-520
Device description
Accell TBM, 5x2 - is made using demineralized human bone and is provided in the form of a freeze-dried matrix in a sheet or “wafer” format. Accell TB
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
10889981055646PrimaryGS10
M3860240005201SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998105564610889981055646

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
00643169964938GRAFTON™ DBMMEDTRONIC SOFAMOR DANEK, INC.MBP2024-12-05
00643169965102GRAFTON PLUS™ DBMMEDTRONIC SOFAMOR DANEK, INC.MBP2024-11-15
00810076560007BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
00810076560380BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
00810076560649BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
00810076560656BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
00810076560663BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
00810076560670BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
00810076560687BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
00810076560694BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
00763000140502PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MBP2021-03-12
00763000140519PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MBP2021-03-12
00763000140526PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MBP2021-03-12
00763000140533PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MBP2021-03-12
00613994247612PROGENIX® PUTTY and PROGENIX® PLUSMEDTRONIC SOFAMOR DANEK, INC.MBP2019-03-29
00643169965089GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.MBP2019-02-07
00643169965096GRAFTON PLUS® DBMMEDTRONIC SOFAMOR DANEK, INC.MBP2018-04-05
00643169965065GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.MBP2018-01-26
00849777004695ProSpace™ DBM Paste (Syringe)Xtant Medical Holdings, Inc.MBP2016-10-18
00849777004701ProSpace™ DBM Paste (Syringe)Xtant Medical Holdings, Inc.MBP2016-10-18
00849777004718ProSpace™ DBM Paste (Syringe)Xtant Medical Holdings, Inc.MBP2016-10-18
00849777004725ProSpace™ DBM Moldable Putty (Jar)Xtant Medical Holdings, Inc.MBP2016-10-18
00849777004732ProSpace™ DBM Moldable Putty (Jar)Xtant Medical Holdings, Inc.MBP2016-10-18
00849777004749ProSpace™ DBM Moldable Putty (Jar)Xtant Medical Holdings, Inc.MBP2016-10-18
00849777004824DBM Putty 2.5cc in a SyringeXtant Medical Holdings, Inc.MBP2016-10-18
00849777004831DBM Putty 5.0cc in a SyringeXtant Medical Holdings, Inc.MBP2016-10-18
00849777005630DBM Putty 10.0cc, AxograftXtant Medical Holdings, Inc.MBP2016-10-18
00849777005647DBM Putty 1.0cc, AxograftXtant Medical Holdings, Inc.MBP2016-10-18
00849777005654DBM Putty 2.5cc, AxograftXtant Medical Holdings, Inc.MBP2016-10-18
00849777005661DBM Putty 5.0cc, AxograftXtant Medical Holdings, Inc.MBP2016-10-18