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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 Class Implantable

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BONE SCREW, EDX - 3.2Ø x 16mm
XNAV TECHNOLOGIES LLC
P010308
In Commercial Distribution

  • 00817421021442 ()
  • 00817421021435 ()
  • 00817421022739 ()
P010308

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable
BONE SCREW, EDX - 3.2Ø x 8mm
XNAV TECHNOLOGIES LLC
P010307
In Commercial Distribution

  • 00817421021428 ()
  • 00817421021411 ()
  • 00817421022722 ()
P010307

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable
BONE SCREW, EDX - 3.2Ø x 4mm
XNAV TECHNOLOGIES LLC
P010306
In Commercial Distribution

  • 00817421021404 ()
  • 00817421021398 ()
  • 00817421022715 ()
P010306

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable
BONE SCREW, EDX - 2.7Ø x 16mm
XNAV TECHNOLOGIES LLC
P010305
In Commercial Distribution

  • 00817421021381 ()
  • 00817421021374 ()
  • 00817421022708 ()
P010305

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable
BONE SCREW, EDX - 2.7Ø x 8mm
XNAV TECHNOLOGIES LLC
P010304
In Commercial Distribution

  • 00817421021367 ()
  • 00817421021350 ()
  • 00817421022692 ()
P010304

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable
BONE SCREW, EDX - 2.7Ø x 4mm
XNAV TECHNOLOGIES LLC
P010303
In Commercial Distribution

  • 00817421021343 ()
  • 00817421021336 ()
  • 00817421022685 ()
P010303

  • Surgical planning/navigation-enhancement system
  • Craniofacial bone screw, non-bioabsorbable
The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connect to the stimulation lead and sensing lead. The Model 3028 does not contain any software or firmware. All functions including the telemetry and algorithm have been designed into the hardware of the IPG. The algorithm synchronizes stimulation of the hypoglossal nerve with respiration signals. The IPG processes the same dynamic range of pressure signals (2-48 cmH2O) in order to account for pressure reading variability. Based on typical settings from the STAR pivotal trial, the longevity of the Model 3028’s battery will average 10 years although the device is smaller than the currently approved version (Model 3024). In addition the Model 3028 IPG will allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.
Inspire Medical Systems, Inc.
900-007-014
In Commercial Distribution

  • 10855728005915 ()
3028

  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connect to the stimulation lead and sensing lead. The Model 3028 does not contain any software or firmware. All functions including the telemetry and algorithm have been designed into the hardware of the IPG. The algorithm synchronizes stimulation of the hypoglossal nerve with respiration signals. The IPG processes the same dynamic range of pressure signals (2-48 cmH2O) in order to account for pressure reading variability. Based on typical settings from the STAR pivotal trial, the longevity of the Model 3028’s battery will average 10 years although the device is smaller than the currently approved version (Model 3024). In addition the Model 3028 IPG will allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.
Inspire Medical Systems, Inc.
900-007-010
In Commercial Distribution

  • 10855728005762 ()
3028

  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connect to the stimulation lead and sensing lead. The Model 3028 does not contain any software or firmware. All functions including the telemetry and algorithm have been designed into the hardware of the IPG. The algorithm synchronizes stimulation of the hypoglossal nerve with respiration signals. The IPG processes the same dynamic range of pressure signals (2-48 cmH2O) in order to account for pressure reading variability. Based on typical settings from the STAR pivotal trial, the longevity of the Model 3028’s battery will average 10 years although the device is smaller than the currently approved version (Model 3024). In addition the Model 3028 IPG will allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.
Inspire Medical Systems, Inc.
900-007-003
In Commercial Distribution

  • 10855728005465 ()
3028

  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connect to the stimulation lead and sensing lead. The Model 3028 does not contain any software or firmware. All functions including the telemetry and algorithm have been designed into the hardware of the IPG. The algorithm synchronizes stimulation of the hypoglossal nerve with respiration signals. The IPG processes the same dynamic range of pressure signals (2-48 cmH2O) in order to account for pressure reading variability. Based on typical settings from the STAR pivotal trial, the longevity of the Model 3028’s battery will average 10 years although the device is smaller than the currently approved version (Model 3024). In addition the Model 3028 IPG will allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.
Inspire Medical Systems, Inc.
900-007-008
In Commercial Distribution

  • 10855728005656 ()
3028

  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
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