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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Mg OSTEOCRETE™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOCRETE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
10cc
In Commercial Distribution

  • B4474410000STR0 ()
44-100-00-STR

  • Bone matrix implant, synthetic, non-antimicrobial
Mg OSTEOINJECT™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOINJECT™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
10cc
In Commercial Distribution

  • B4474410000INJ0 ()
44-100-00-INJ

  • Bone matrix implant, synthetic, non-antimicrobial
Mg OSTEOCRETE™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOCRETE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
10cc
In Commercial Distribution

  • B4474410000BSI0 ()
44-100-00-BSI

  • Bone matrix implant, synthetic, non-antimicrobial
Mg OSTEOCRETE™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOCRETE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
5cc
In Commercial Distribution

  • B4474405000STR0 ()
44-050-00-STR

  • Bone matrix implant, synthetic, non-antimicrobial
Mg OSTEOREVIVE™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOREVIVE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
5cc
In Commercial Distribution

  • B4474405000REV0 ()
44-050-00-REV

  • Bone matrix implant, synthetic, non-antimicrobial
Mg OSTEOINJECT™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOINJECT™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
5cc
In Commercial Distribution

  • B4474405000INJ0 ()
44-050-00-INJ

  • Bone matrix implant, synthetic, non-antimicrobial
Mg OSTEOCRETE™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOCRETE™ Packet contains powder (Magnesium based compound) and a mixing solution (modified saline). The device is sterile, single use only.
BONE SOLUTIONS, INC.
5cc
In Commercial Distribution

  • B4474405000BSI0 ()
44-050-00-BSI

  • Bone matrix implant, synthetic, non-antimicrobial
The Titan Reverse Shoulder humeral body is made of titanium. It is designed for potential increased ROM and minimized scapular notching, as well as increased visual and access to glenoid. The asymmatrix coating allows for an all press fit humeral component and secondary fixation. A titanium screw is included for fixation.
Ascension Orthopedics, Inc.
BBS096021LRG
In Commercial Distribution

  • M269BBS096021LRG1 ()
  • 10381780121541 ()

  • 08 Large; .825 in L x .186 in dia Screw
BBS-0960-21LRG

  • Reverse shoulder prosthesis body
The Titan Reverse Shoulder humeral body is made of titanium. It is designed for potential increased ROM and minimized scapular notching, as well as increased visual and access to glenoid. The asymmatrix coating allows for an all press fit humeral component and secondary fixation. A titanium screw is included for fixation.
Ascension Orthopedics, Inc.
BBS096021STD
In Commercial Distribution

  • M269BBS096021STD1 ()
  • 10381780121534 ()

  • 08 Standard; .825 in L x .186 in dia Screw
BBS-0960-21STD

  • Reverse shoulder prosthesis body
The Titan Reverse Shoulder humeral body is made of titanium. It is designed for potential increased ROM and minimized scapular notching, as well as increased visual and access to glenoid. The asymmatrix coating allows for an all press fit humeral component and secondary fixation. A titanium screw is included for fixation.
Ascension Orthopedics, Inc.
BBS096021SML
In Commercial Distribution

  • 10381780121527 ()
  • M269BBS096021SML1 ()

  • 08 Small; .825 in L x .186 in dia Screw
BBS-0960-21SML

  • Reverse shoulder prosthesis body
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