FDA.reportPublic FDA data

Mixing and Delivery System

Primary DI
B447RM4405110
Brand
Mixing and Delivery System
Company
BONE SOLUTIONS, INC.
Model
Mechanical Advantage Pak
Catalog number
RM 44-051
Device description
The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
Published
2020-07-30
Public version status
Update
Distribution status
Not 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
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B447RM4405110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone graft delivery kitA collection of sterile devices intended to be used to prepare and/or deliver bone graft material during an orthopaedic surgical procedure. It typically includes aspirating/delivery/mixing syringe(s), an adaptor, and a needle/cannula. It allows for the aspiration and/or premixing of bone marrow, autologous blood, plasma, intravenous fluids (IVF), and bone void filler (e.g., allograft, autograft, synthetic bone graft material), and their delivery to the surgical site. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8178098850customerservice@bonesolutions.net

Regulatory Flags#

DUNS number
003506272
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850080243145T-Han Delivery System4.2 x 180mmRM44-0532026-02-13
00850080243152T-Han Delivery System4.2 x 350mmRM44-0632026-02-13
00850080243169T-Han Delivery System4.2 x 450mmRM44-0732026-02-13
B4474410000INJ0Mg OSTEOINJECT® bone graft substitute10cc44-100-00-INJ2024-05-20
B4474405000REV0Mg OSTEOREVIVE™ bone graft substitute5cc44-050-00-REV2022-02-02
B4474410000REV0Mg OSTEOREVIVE™ bone graft substitute10cc44-100-00-REV2022-02-02
B4474415000REV0Mg OSTEOREVIVE™ bone graft substitute15cc44-150-00-REV2022-02-02
B4474405000INJ0Mg OSTEOINJECT® bone graft substitute 5cc44-050-00-INJ2022-01-11
B4477120010Mixing and Delivery SystemBeat Mat Pak7120012021-09-27
B447RM4405010Mixing and Delivery SystemBeat Mat PakRM44-0502020-07-30
B4474405000STR0Mg OSTEOCRETE™ bone graft substitute5cc44-050-00-STR2020-02-19
B4474410000BSI0Mg OSTEOCRETE™ bone graft substitute10cc44-100-00-BSI2020-02-19
B4474410000STR0Mg OSTEOCRETE™ bone graft substitute10cc44-100-00-STR2020-02-19
B4474415000BSI0Mg OSTEOCRETE™ bone graft substitute15cc44-150-00-BSI2020-02-19
B4474415000STR0Mg OSTEOCRETE™ bone graft substitute15cc44-150-00-STR2020-02-19
B4474405000BSI0Mg OSTEOCRETE™ bone graft substitute5cc44-050-00-BSI2017-08-04
B4477120000Opus Mg Set - Mixing and Delivery SystemAUX7120002021-09-27
B4477120050Opus Mg Set BVF5cc7120052021-09-27
B4477120100Opus Mg Set BVF10cc7120102021-09-27
B4477120150Opus Mg Set BVF15cc7120152021-09-27

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Primary DI, Brand, Company table
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