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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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OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinforced with a titanium mesh plate which together provide the mechanical performance, safety and efficacy properties. The fully cured calcium phosphate ceramic fills the void in the burr hole. The osteoconductive ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is sized to match standard 11mm and 14mm burr hole perforators. (510(k) no. K181539)
Ossdsign AB
11 mm, 6 fixation-points
Not in Commercial Distribution

  • 17350086550259 ()
  • 07350086550252 ()
  • 27350086550256 ()

  • 6 fixation-points
  • Outer Diameter: 11 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinforced with a titanium mesh plate which together provide the mechanical performance, safety and efficacy properties. The fully cured calcium phosphate ceramic fills the void in the burr hole. The osteoconductive ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is sized to match standard 11mm and 14mm burr hole perforators. (510(k) no. K181539)
Ossdsign AB
11 mm, 2 fixation-points
Not in Commercial Distribution

  • 17350086550242 ()
  • 07350086550245 ()
  • 27350086550249 ()

  • 2 fixation-points
  • Outer Diameter: 11 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinforced with a titanium mesh plate which together provide the mechanical performance, safety and efficacy properties. The fully cured calcium phosphate ceramic fills the void in the burr hole. The osteoconductive ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is sized to match standard 11mm and 14mm burr hole perforators. (510(k) no. K181539)
Ossdsign AB
14 mm, 6 fixation-points
Not in Commercial Distribution

  • 17350086550235 ()
  • 07350086550238 ()
  • 27350086550232 ()

  • 6 fixation-points
  • Outer Diameter: 14 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinforced with a titanium mesh plate which together provide the mechanical performance, safety and efficacy properties. The fully cured calcium phosphate ceramic fills the void in the burr hole. The osteoconductive ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is sized to match standard 11mm and 14mm burr hole perforators. (510(k) no. K181539)
Ossdsign AB
14 mm, 2 fixation-points
Not in Commercial Distribution

  • 07350086550221 ()
  • 17350086550228 ()
  • 27350086550225 ()

  • 2 fixation-points
  • Outer Diameter: 14 Millimeter
n/a

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Model 3001 ISA, Sterile Cable Pack, Sensor/Driver-to-PID
Envoy Medical Corporation
3200
In Commercial Distribution

  • 00812282020610 ()
903200-002

  • Fully-implantable middle ear implant system
Intraoperative System Analyzer (ISA), Sterile Cable, PID to Driver
Envoy Medical Corporation
3001
In Commercial Distribution

  • 00812282020443 ()
803045-002

  • Fully-implantable middle ear implant system
Driver Model 7510, IS-1 Connector
Envoy Medical Corporation
7510
In Commercial Distribution

  • 00812282020030 ()
907510-001

  • Fully-implantable middle ear implant system
Driver Model 7504, IS-1 Connector
Envoy Medical Corporation
7504
In Commercial Distribution

  • 00812282020023 ()
907504-003

  • Fully-implantable middle ear implant system
Driver Model 7504, IS-1 Connector
Envoy Medical Corporation
7504
In Commercial Distribution

  • 00812282020016 ()
907504-001

  • Fully-implantable middle ear implant system
MESH, 3D, ULTRAONE, NEURO SCREW, CP TITANIUM
KLS-Martin L.P.
25-008-77-71
In Commercial Distribution

  • 00888118114631 ()

  • 170 X 138 MM, T=1.0 MM


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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