FDA.reportPublic FDA data

Actifuse Flow

Primary DI
55060050780765
Brand
Actifuse Flow
Company
Apatech Ltd
Model
506005078076
Catalog number
506005078076
Device description
Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 1.5ml pack size
Published
2018-10-10
Public version status
New
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
K181306000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181306000Actifuse FlowBaxter Healthcare Corporation2018-08-17MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
55060050780765PackageGS11In Commercial Distribution
05060050780760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5506005078076555060050780765
05060050780760050600507807605060050780760

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, syntheticA sterile bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1.5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius32 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)933-0303MEDINFO_MEDPRODUCTS@BAXTER.COM

Regulatory Flags#

DUNS number
221517829
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
05413760467450Ostene150383115038312015-09-24
05413760467467Ostene150383215038322015-09-24
05413760467474Ostene150383315038332015-09-24
05060050780289Actifuse Granules5060050780285060050780282015-09-24
05060050780296Actifuse Granules5060050780295060050780292015-09-24
05060050780302Actifuse Granules5060050780305060050780302015-09-24
05060050780449Actifuse Microgranules5060050780445060050780442015-09-24
05060050780456Actifuse Microgranules5060050780455060050780452015-09-24
05060050780463Actifuse Microgranules5060050780465060050780462015-09-24
05060050780500Actifuse ABX5060050780505060050780502015-09-24
05060050780517Actifuse ABX5060050780515060050780512015-09-24
05060050780524Actifuse ABX5060050780525060050780522015-09-24
05060050780548Actifuse E-Z-Prep5060050780545060050780542015-09-24
05060050780562Actifuse Granules5060050780565060050780562015-09-24
05060050780586Actifuse ABX5060050780585060050780582015-09-24
05060050780609Actifuse ABX5060050780605060050780602015-09-24
05060050780623Actifuse Shape5060050780625060050780622015-09-24
05060050780647Actifuse Shape5060050780645060050780642015-09-24
05060050780661Actifuse Shape5060050780665060050780662015-09-24
05060050780685Actifuse Shape5060050780685060050780682015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816125027132VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
00816125027149VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
ECUR9920302VerteFramecurasan AGMQV2026-06-25
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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
06429810349330Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349354Adaptos®FuseBiomendex OyMQV2026-06-24
W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.MQV2026-06-05
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07610221017836Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017843Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017850Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01