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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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MESA® Spinal System - 10888857137257

Foundation Screw Size Ø8.5x110 mm
K2M, INC.
801-085110D-SG
In Commercial Distribution

  • 10888857137257 ()

  • Length: 110 Millimeter
  • Outer Diameter: 8.5 Millimeter
801-085110D-SG

  • Spinal bone screw, non-bioabsorbable

GEM™ Synthetic Bone Graft - 00850001118163

Synthetic Mineral-Collagen Composite Bone Graft, 0.5cc (9mm x 8mm)
LYNCH BIOLOGICS, LLC
LBSB050
Not in Commercial Distribution

  • 00850001118163 ()


  • Collagen dental regeneration membrane

GEM™ Bone Graft - 00850001118156

Osteoconductive Bone Matrix in Syringe, 0.5cc (Particle Size 0.25-1.0mm)
LYNCH BIOLOGICS, LLC
LBNBS05
Not in Commercial Distribution

  • 00850001118156 ()


  • Dental bone matrix implant, animal-derived

GEM™ Bone Graft - 00850001118149

Osteoconductive Bone Matrix in Syringe, 0.25cc (Particle Size 0.25-1.0mm)
LYNCH BIOLOGICS, LLC
LBNBS025
Not in Commercial Distribution

  • 00850001118149 ()


  • Dental bone matrix implant, animal-derived

GEM™ Bone Graft - 00850001118132

Osteoconductive Bone Matrix, 2.0cc (Particle Size 1.0-2.0mm)
LYNCH BIOLOGICS, LLC
LBNB2020
Not in Commercial Distribution

  • 00850001118132 ()


  • Dental bone matrix implant, animal-derived

GEM™ Bone Graft - 00850001118125

Osteoconductive Bone Matrix, 1.0cc (Particle Size 1.0-2.0mm)
LYNCH BIOLOGICS, LLC
LBNB1020
Not in Commercial Distribution

  • 00850001118125 ()


  • Dental bone matrix implant, animal-derived

GEM™ Bone Graft - 00850001118118

Osteoconductive Bone Matrix, 4.0cc (Particle Size 0.25-1.0mm)
LYNCH BIOLOGICS, LLC
LBNB4010
Not in Commercial Distribution

  • 00850001118118 ()


  • Dental bone matrix implant, animal-derived

MESA® Spinal System - 10888857137073

Polyaxial Screw Size Ø7.5x65 mm
K2M, INC.
801-07565-SG
In Commercial Distribution

  • 10888857137073 ()

  • Length: 65 Millimeter
  • Outer Diameter: 7.5 Millimeter
801-07565-SG

  • Spinal bone screw, non-bioabsorbable

GEM Cap™ - 00850001118071

Resorbable Collagen Membrane, 12mm x 16mm
LYNCH BIOLOGICS, LLC
LBCAP1216
Not in Commercial Distribution

  • 00850001118071 ()

  • Width: 16 Millimeter
  • Length: 12 Millimeter


  • Collagen dental regeneration membrane

GEM Extend™ - 00850001118057

Resorbable Collagen Membrane, 20mm x 30mm
LYNCH BIOLOGICS, LLC
LBEXT2030
Not in Commercial Distribution

  • 00850001118057 ()

  • Width: 30 Millimeter
  • Length: 20 Millimeter


  • Collagen dental regeneration membrane
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