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
Biomet Orthopedics, LLC
14-410008
In Commercial Distribution

  • 00887868093043 ()
14-410008

  • Cannulated surgical drill bit, single-use
No Description
Biomet Orthopedics, LLC
14-410006
In Commercial Distribution

  • 00887868093029 ()
14-410006

  • Cannulated surgical drill bit, single-use
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
No Description
Biomet Orthopedics, LLC
14-451567
In Commercial Distribution

  • 00887868129780 ()

  • 4.5MM
14-451567

  • Surgical screwdriver, single-use
Stratum Ankle Outrigger 3.5MM Hex Driver sterile
Medartis Inc.
SAOUT35DRVS
In Commercial Distribution

  • 00810082893281 ()


  • Surgical screwdriver, single-use
Stratum Ankle Outrigger Cannulated Drill sterile
Medartis Inc.
SAOUTCANS
In Commercial Distribution

  • 00810082893229 ()


  • Cannulated surgical drill bit, single-use
Stratum Ankle T20 AO Driver sterile
Medartis Inc.
SAT20AOS
In Commercial Distribution

  • 00810082893090 ()


  • Surgical screwdriver, single-use
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