FDA.reportPublic FDA data

OSTEOFUSE

Primary DI
00816986020099
Brand
OSTEOFUSE
Company
BIOVENTUS LLC
Model
7.5g
Catalog number
OF002
Device description
Bioactive Bone Graft Putty
Published
2019-02-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K132071000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132071000BIOACTIVE BONE GRAFT PUTTYBiostructures, LLC2014-01-10MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816986020099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816986020099008169860200998169860200990816986020099

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.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078450878
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M937710346601EXOGEN Metatarsal Strap710346602021-12-17
M937710344001EXOGEN® Ultrasound Bone Healing System71034400710344002017-01-12
M937710346001EXOGEN® Ultrasound Bone Healing System71034600710346002017-01-12
00816986020549TalisMann Implant KitTM-10002025-09-01
00816986020556StimTrial Surgical KitTS-10002025-09-01
00816986020570StimTrial Patient KitTS-60002025-09-01
00816986020587StimTrial Stimulator KitTS-50002025-09-01
00816986020617Bioventus User KitPNS-50002025-09-01
00816986020624Bioventus Clinician KitPNS-10002025-09-01
10389130444418SUPARTZ FX sodium hyaluronate715644442023-09-28
00816986020525Osteoamp Flowable Access CannulaOFAC-COFAC-C2024-11-21
00816986020037INTERFACEIFBG100IFBG1002019-05-06
00816986020488SIGNAFUSE Bioactive Bone Graft25X25X8 MM, 5 CCSGFS-0052020-07-30
00816986020495SIGNAFUSE Bioactive Bone Graft50X25X8 MM, 10 CCSGFS-0102020-07-30
00816986020501SIGNAFUSE Bioactive Bone Graft100X25X8 MM, 20 CCSGFS-0202020-07-30
00816986020518SIGNAFUSE Bioactive Bone Graft200X25X8 MM, 40 CCSGFS-0402020-07-30
00816986020006SIGNAFUSE15gSGF-1502019-02-22
00816986020013SIGNAFUSE7.5gSGF-0752019-02-22
00816986020020SIGNAFUSE3.75gSGF-0372019-02-22
00816986020082OSTEOFUSE3.75gOF0012019-02-22

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Primary DI, Brand, Company table
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