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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 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
The Titan Modular Total Shoulder cemented stem is shaped to provide proximal fixation. This stem is smooth and fluted, allowing for cement fixation and rotational control. It has 5 stem diameters ranging from 6-14 mm to address varying humeral sizes. The cemented stem is tapered and polished for ease of insertion.
Ascension Orthopedics, Inc.
SEM095002514
In Commercial Distribution

  • 10381780120643 ()
  • M268STEM0950025141 ()

  • 3.86 in L x .550 in dia; Size 14
STEM-0950-025-14

  • Surgical soft-tissue manipulation forceps, alligator, reusable
The Titan Modular Total Shoulder cemented stem is shaped to provide proximal fixation. This stem is smooth and fluted, allowing for cement fixation and rotational control. It has 5 stem diameters ranging from 6-14 mm to address varying humeral sizes. The cemented stem is tapered and polished for ease of insertion.
Ascension Orthopedics, Inc.
SEM095002512
In Commercial Distribution

  • 10381780120636 ()
  • M268STEM0950025121 ()

  • 3.86 in L x .470 in dia; Size 12
STEM-0950-025-12

  • Coated shoulder humeral stem prosthesis
The Titan Modular Total Shoulder cemented stem is shaped to provide proximal fixation. This stem is smooth and fluted, allowing for cement fixation and rotational control. It has 5 stem diameters ranging from 6-14 mm to address varying humeral sizes. The cemented stem is tapered and polished for ease of insertion.
Ascension Orthopedics, Inc.
SEM095002510
In Commercial Distribution

  • 10381780120629 ()
  • M268STEM0950025101 ()

  • 3.86 in L x .390 in dia; Size 10
STEM-0950-025-10

  • Coated shoulder humeral stem prosthesis
The Titan Modular Total Shoulder cemented stem is shaped to provide proximal fixation. This stem is smooth and fluted, allowing for cement fixation and rotational control. It has 5 stem diameters ranging from 6-14 mm to address varying humeral sizes. The cemented stem is tapered and polished for ease of insertion.
Ascension Orthopedics, Inc.
SEM095002508
In Commercial Distribution

  • 10381780120612 ()
  • M268STEM0950025081 ()

  • 3.86 in L x .320 in dia; Size 08
STEM-0950-025-08

  • Coated shoulder humeral stem prosthesis
The Titan Modular Total Shoulder cemented stem is shaped to provide proximal fixation. This stem is smooth and fluted, allowing for cement fixation and rotational control. It has 5 stem diameters ranging from 6-14 mm to address varying humeral sizes. The cemented stem is tapered and polished for ease of insertion.
Ascension Orthopedics, Inc.
SEM095002506
In Commercial Distribution

  • 10381780120605 ()
  • M268STEM0950025061 ()

  • 3.86 in L x .240 in dia; Size 06
STEM-0950-025-06

  • Coated shoulder humeral stem prosthesis
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