BonVie+

Primary DI
00199284455788
Brand
BonVie+
Company
ELUTE , INC.
Model
EPBV-10ML
Catalog number
EPBV-10ML
Device description
BonVie+ is a sterile, single-use, osteoconductive bone void filler intended to fill bony voids or gaps in the extremities and pelvis. It is supplied as a kit that includes a calcium salt and polymer powder, a mixing solution, and a silicone mat with cavities to form granules of various sizes. As the device resorbs, new bone gradually grows into the space previously occupied by the implant and replaces it during the healing process.
Published
2025-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
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
K250346000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250346000BonVie+Elute, Inc.2025-02-26MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00199284455788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00199284455788001992844557881992844557880199284455788

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, synthetic, non-antimicrobialA 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 does not include an antimicrobial agent(s). 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 Volume10Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(801)-410-4330info@elutinc.com

Regulatory Flags#

DUNS number
968551015
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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