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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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No Description
Reison Medical AB
11443
In Commercial Distribution

  • 07350111832537 ()


  • External orthopaedic fixation system, reusable
No Description
Reison Medical AB
10-393
In Commercial Distribution

  • 07350111832438 ()


  • External orthopaedic fixation system, reusable
No Description
Reison Medical AB
10-392
In Commercial Distribution

  • 07350111832421 ()


  • External orthopaedic fixation system, reusable
No Description
Reison Medical AB
10-367-K
In Commercial Distribution

  • 07350111831554 ()


  • External orthopaedic fixation system, reusable
No Description
Reison Medical AB
10-367
In Commercial Distribution

  • 07350111831547 ()


  • External orthopaedic fixation system, reusable
No Description
Reison Medical AB
10-353-18-B
In Commercial Distribution

  • 07350111831455 ()


  • External orthopaedic fixation system, reusable
No Description
Reison Medical AB
10-353
In Commercial Distribution

  • 07350111831431 ()


  • External orthopaedic fixation system, reusable
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
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