FDA.reportPublic FDA data

Genex Bone Graft Substitute

Primary DI
15060155711482
Brand
Genex Bone Graft Substitute
Company
BIOCOMPOSITES LTD
Model
910-005Z
Catalog number
910-005Z
Device description
genex® Bone Graft Substitute is a simple to use synthetic absorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. The kit contains a powder filled syringe and mixing solution which, when combined, provides a mouldablecohesive paste which may be implanted into open voids/gaps of the musculoskeletal system to set insitu or placed in the bead mould mat provided to form beads for implantation. When injected the mixturesets to form genex® Bone Graft substitute a hard but absorbable matrix. genex® Bone Graft Substituteis supplied sterile. genex® Bone Graft Substitute , accessories and packaging are not made from natural rubber latex.genex® Bone Graft Substitute is MR safe.
Published
2022-02-17
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
K212721000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212721000Genex Bone Graft SubstituteBiocomposites, Ltd.2022-02-04MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060155711482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506015571148215060155711482

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic bone graftAn artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4401782338580info@biocomposites.com

Regulatory Flags#

DUNS number
424382307
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060155712205Synicem Knee Spacer Trial Tray with Trials8820248820242025-07-08
15060155712328Synicem 58 Knee Trial FDA8854188854182025-07-08
15060155712342Synicem 65 Knee Trial FDA8854198854192025-07-08
15060155712366Synicem 72 Knee Trial FDA8854208854202025-07-08
15060155712380Synicem 79 Knee Trial FDA8854218854212025-07-08
15060155712700Synicem Knee Spacer Trial Case (marked)5150905150902025-07-08
15060155712021Synicem Hip Spacer 40C8854308854302025-07-08
15060155712038Synicem Hip Spacer 48C8854318854312025-07-08
15060155712045Synicem Hip Spacer 56C8854328854322025-07-08
15060155712052Synicem Hip Spacer 40CXL8854338854332025-07-08
15060155712069Synicem Hip Spacer 48CXL8854348854342025-07-08
15060155712076Synicem Hip Spacer 56CXL8854358854352025-07-08
15060155712083Synicem Hip Spacer 48M8854368854362025-07-08
15060155712090Synicem Hip Spacer 56M8854378854372025-07-08
15060155712106Synicem Hip Spacer Trial Tray Regular with Trials8820228820222025-07-08
15060155712113Synicem Hip Spacer Trial Tray XL with Trials8820238820232025-07-08
15060155712120Synicem Knee Spacer R588854388854382025-07-08
15060155712137Synicem Knee Spacer L588854398854392025-07-08
15060155712144Synicem Knee Spacer R658854408854402025-07-08
15060155712151Synicem Knee Spacer L658854418854412025-07-08

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