FDA.reportPublic FDA data

Bio V BP Bioactive Glass with DBM Putty - 2.0 cc

Primary DI
00858686006058
Brand
Bio V BP Bioactive Glass with DBM Putty - 2.0 cc
Company
AMEND SURGICAL, INC.
Model
BGP001-02
Catalog number
BGP001-02
Device description
Synthetic bone void filler containing DBM for orthopedic applications, provided in a syringe dispenser
Published
2017-11-10
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)Orthopedic2
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142104000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142104000NANOFUSE DBMNanotherapeutics, Inc.2015-01-21MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858686006058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858686006058008586860060588586860060580858686006058

GMDN Terms#

Term, Definition table
TermDefinition
Cadaveric-donor/synthetic mineral bone graftA sterile implantable device consisting of demineralized bone matrix (DBM) processed from cadaveric human bone (allograft) and mixed with bioabsorbable synthetic minerals (e.g., calcium phosphate), intended to fill bony voids or gaps in the skeletal system (e.g., spine, pelvis, extremities) that have been surgically or traumatically created; it may also serve as a bone graft extender. It is designed to be resorbed/remodelled and replaced by host bone during the healing process. It is typically supplied as a kit which requires mixing to form a putty-like substance prior to implantation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume2Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius37 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8442813169smathison@amendsurgical.com

Regulatory Flags#

DUNS number
080131031
Device count
1
HCT/P
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858686006089NanoFUSE Bioactive Strip50x25x7mmASI209-102019-07-16
00858686006096NanoFUSE Bioactive Strip100x25x7mmASI209-202019-07-16
00858686006003NanoFuse Bioactive Matrix - 2.0 ccNAN109-02NAN109-022016-08-12
00858686006010NanoFuse Bioactive Matrix - 5.0 ccNAN109-05NAN109-052016-08-12
00858686006027NanoFuse Bioactive Matrix - 10.0 ccNAN109-10NAN109-102016-08-12
00858686006034NanoFuse Bioactive Matrix - 1.0 ccNAN109-01NAN109-012018-01-12
00858686006041Bio V BP Bioactive Glass with DBM PuttyBGP001-01BGP001-012018-01-12
00858686006065Bio V BP Bioactive Glass with DBM Putty - 5.0 ccBGP001-05BGP001-052017-11-10
00858686006072Bio V BP Bioactive Glass with DBM PuttyBGP001-10BGP001-102017-11-10

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Primary DI, Brand, Company table
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ECURTFM1100TriForm Moldable Foamcurasan AGMQV2026-06-25
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