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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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TI HBS self-drilling high compression screw,cannulated,28mm - EMAHHBS100228S0

TI HBS self-drilling high compression screw,cannulated,28mm
mahe medical gmbh
HBS-1002-28S
In Commercial Distribution

  • EMAHHBS100228S1 ()
  • EMAHHBS100228S0 ()

  • Length: 28 Millimeter
  • Outer Diameter: 3.0 Millimeter
HBS-1002-28S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Screw 4.5 x 28mm s/s self-tapping - EMAH9305450280

Screw 4.5 x 28mm s/s self-tapping
mahe medical gmbh
930545028
In Commercial Distribution

  • EMAH9305450281 ()
  • EMAH9305450280 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 28 Millimeter
930545028

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

A.M.I.-dock Bluntdissect DLU 10mm - EAMIA101310

Loading unit for blunt dissection for A.M.I.-dock Applicator 10mm. The Bluntdissect DLU`s are part of the A.M.I.-dock System which is a set of instruments intended for using during laparoscopic surgical procedures. The system consists of: - various A.M.I.-dock Applicators, delivered non sterile, - various A.M.I.-dock DLU’s (Disposable Loading Units), sterile packed, for different applications in the OR.
AMI Agency for Medical Innovations GmbH
A10 131
Not in Commercial Distribution

  • EAMIA101310 ()
  • EAMIA101311 ()

  • Length: 28 Millimeter
  • Outer Diameter: 8 Millimeter
A10 131

  • Dissection sponge

Axle Interspinous Fusion System - M697T08038281912TR1

Irix A 38 x 28 x 19mm, 12 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382819-12TR
In Commercial Distribution

  • M697T08038281912TR0 ()
  • M697T08038281912TR1 ()

  • Height: 19 Millimeter
  • Length: 28 Millimeter
  • Angle: 12 degree
  • Width: 38 Millimeter


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697T08038281908TR1

Irix A 38 x 28 x 19mm, 8 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382819-08TR
In Commercial Distribution

  • M697T08038281908TR0 ()
  • M697T08038281908TR1 ()

  • Height: 19 Millimeter
  • Length: 28 Millimeter
  • Width: 38 Millimeter
  • Angle: 8 degree


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697T08038281712TR1

Irix A 38 x 28 x 17mm, 12 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382817-12TR
In Commercial Distribution

  • M697T08038281712TR0 ()
  • M697T08038281712TR1 ()

  • Angle: 12 degree
  • Width: 38 Millimeter
  • Height: 17 Millimeter
  • Length: 28 Millimeter


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697T08038281708TR1

Irix A 38 x 28 x 17mm, 8 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382817-08TR
In Commercial Distribution

  • M697T08038281708TR0 ()
  • M697T08038281708TR1 ()

  • Width: 38 Millimeter
  • Length: 28 Millimeter
  • Angle: 8 degree
  • Height: 17 Millimeter


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697T08038281512TR1

Irix A 38 x 28 x 15mm, 12 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382815-12TR
In Commercial Distribution

  • M697T08038281512TR0 ()
  • M697T08038281512TR1 ()

  • Width: 38 Millimeter
  • Angle: 12 degree
  • Length: 28 Millimeter
  • Height: 15 Millimeter


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697T08038281508TR1

Irix A 38 x 28 x 15mm, 8 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382815-08TR
In Commercial Distribution

  • M697T08038281508TR0 ()
  • M697T08038281508TR1 ()

  • Width: 38 Millimeter
  • Length: 28 Millimeter
  • Angle: 8 degree
  • Height: 15 Millimeter


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697T08038281312TR1

Irix A 38 x 28 x 13mm, 12 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382813-12TR
In Commercial Distribution

  • M697T08038281312TR0 ()
  • M697T08038281312TR1 ()

  • Length: 28 Millimeter
  • Width: 38 Millimeter
  • Height: 13 Millimeter
  • Angle: 12 degree


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697T08038281308TR1

Irix A 38 x 28 x 13mm, 8 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382813-08TR
In Commercial Distribution

  • M697T08038281308TR0 ()
  • M697T08038281308TR1 ()

  • Width: 38 Millimeter
  • Height: 13 Millimeter
  • Angle: 8 degree
  • Length: 28 Millimeter


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697T08038281112TR1

Irix A 38 x 28 x 11mm, 12 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382811-12TR
In Commercial Distribution

  • M697T08038281112TR0 ()
  • M697T08038281112TR1 ()

  • Angle: 12 degree
  • Length: 28 Millimeter
  • Width: 38 Millimeter
  • Height: 11 Millimeter


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697T08038281108TR1

Irix A 38 x 28 x 11mm, 8 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-382811-08TR
In Commercial Distribution

  • M697T08038281108TR0 ()
  • M697T08038281108TR1 ()

  • Angle: 8 degree
  • Height: 11 Millimeter
  • Length: 28 Millimeter
  • Width: 38 Millimeter


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697T08038281

IMPLANT INSERTER TIP, 38 x 28mm
Xtant Medical Holdings, Inc.
T080-3828
In Commercial Distribution

  • M697T08038280 ()
  • M697T08038281 ()

  • Width: 38 Millimeter
  • Length: 28 Millimeter


  • Polymeric spinal fusion cage, sterile

Axle Interspinous Fusion System - M697X0606028LX1

MODULAR TIP, LOCKING PLATE, 28mm; ALL-IN-ONE PARALLEL INSERTER AXLE X SYSTEM
Xtant Medical Holdings, Inc.
X060-6028LX
In Commercial Distribution

  • M697X0606028LX0 ()
  • M697X0606028LX1 ()

  • Length: 28 Millimeter


  • Lumbar interspinous decompression instrument set, reusable

Axle Interspinous Fusion System - M697X0606028L1

MODULAR TIP, LOCKING PLATE, 28mm; ALL-IN-ONE PARALLEL INSERTER AXLES SYSTEM
Xtant Medical Holdings, Inc.
X060-6028L
In Commercial Distribution

  • M697X0606028L0 ()
  • M697X0606028L1 ()

  • Length: 28 Millimeter


  • Lumbar interspinous decompression instrument set, reusable

Axle Interspinous Fusion System - M697X0606028C1

Axle All-In-One Parallel, Modular Tip, Cross Bar Plate, 28mm
Xtant Medical Holdings, Inc.
X060-6028C
In Commercial Distribution

  • M697X0606028C0 ()
  • M697X0606028C1 ()

  • Length: 28 Millimeter


  • Lumbar interspinous decompression instrument set, reusable

Axle Interspinous Fusion System - M697X06005431

Plate Sizer 28mm Assy
Xtant Medical Holdings, Inc.
X060-0543
In Commercial Distribution

  • M697X06005430 ()
  • M697X06005431 ()

  • Length: 28 Millimeter


  • Lumbar interspinous decompression instrument set, reusable

Opteryx® - M711CP280

Ti 6Al 4V (ELI)
Innovasis, Inc.
CP28
In Commercial Distribution

  • M711CP280 ()

  • Length: 28 Millimeter
CP28

  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

Tx™ - M711LS39716120

Ti 6Al 4V (ELI)
Innovasis, Inc.
LS-397-1612
In Commercial Distribution

  • M711LS39716120 ()

  • Angle: 12.5 degree
  • Length: 28 Millimeter
  • Height: 16 Millimeter
  • Width: 10 Millimeter
LS-397-1612

  • Spinal implant trial

Tx™ - M711LS39716100

Ti 6Al 4V (ELI)
Innovasis, Inc.
LS-397-1610
In Commercial Distribution

  • M711LS39716100 ()

  • Angle: 10 degree
  • Length: 28 Millimeter
  • Height: 16 Millimeter
  • Width: 10 Millimeter
LS-397-1610

  • Spinal implant trial

Tx™ - M711LS39716050

Ti 6Al 4V (ELI)
Innovasis, Inc.
LS-397-1605
In Commercial Distribution

  • M711LS39716050 ()

  • Angle: 5 degree
  • Length: 28 Millimeter
  • Height: 16 Millimeter
  • Width: 10 Millimeter
LS-397-1605

  • Spinal implant trial

Tx™ - M711LS39715120

Ti 6Al 4V (ELI)
Innovasis, Inc.
LS-397-1512
In Commercial Distribution

  • M711LS39715120 ()

  • Angle: 12.5 degree
  • Length: 28 Millimeter
  • Height: 15 Millimeter
  • Width: 10 Millimeter
LS-397-1512

  • Spinal implant trial

Tx™ - M711LS39715100

Ti 6Al 4V (ELI)
Innovasis, Inc.
LS-397-1510
In Commercial Distribution

  • M711LS39715100 ()

  • Angle: 10 degree
  • Length: 28 Millimeter
  • Height: 15 Millimeter
  • Width: 10 Millimeter
LS-397-1510

  • Spinal implant trial

Tx™ - M711LS39715050

Ti 6Al 4V (ELI)
Innovasis, Inc.
LS-397-1505
In Commercial Distribution

  • M711LS39715050 ()

  • Angle: 5 degree
  • Length: 28 Millimeter
  • Height: 15 Millimeter
  • Width: 10 Millimeter
LS-397-1505

  • Spinal implant trial

Tx™ - M711LS39714120

Ti 6Al 4V (ELI)
Innovasis, Inc.
LS-397-1412
In Commercial Distribution

  • M711LS39714120 ()

  • Angle: 12.5 degree
  • Length: 28 Millimeter
  • Height: 14 Millimeter
  • Width: 10 Millimeter
LS-397-1412

  • Spinal implant trial

Tx™ - M711LS39714100

Ti 6Al 4V (ELI)
Innovasis, Inc.
LS-397-1410
In Commercial Distribution

  • M711LS39714100 ()

  • Angle: 10 degree
  • Length: 28 Millimeter
  • Height: 14 Millimeter
  • Width: 10 Millimeter
LS-397-1410

  • Spinal implant trial

Tx™ - M711LS39714050

Ti 6Al 4V (ELI)
Innovasis, Inc.
LS-397-1405
In Commercial Distribution

  • M711LS39714050 ()

  • Angle: 5 degree
  • Length: 28 Millimeter
  • Height: 14 Millimeter
  • Width: 10 Millimeter
LS-397-1405

  • Spinal implant trial

Tx™ - M711LS39713120

Ti 6Al 4V (ELI)
Innovasis, Inc.
LS-397-1312
In Commercial Distribution

  • M711LS39713120 ()

  • Angle: 12.5 degree
  • Length: 28 Millimeter
  • Height: 13 Millimeter
  • Width: 10 Millimeter
LS-397-1312

  • Spinal implant trial

Tx™ - M711LS39713100

Ti 6Al 4V (ELI)
Innovasis, Inc.
LS-397-1310
In Commercial Distribution

  • M711LS39713100 ()

  • Angle: 10 degree
  • Length: 28 Millimeter
  • Height: 13 Millimeter
  • Width: 10 Millimeter
LS-397-1310

  • Spinal implant trial

Tx™ - M711LS39713050

Ti 6Al 4V (ELI)
Innovasis, Inc.
LS-397-1305
In Commercial Distribution

  • M711LS39713050 ()

  • Angle: 5 degree
  • Length: 28 Millimeter
  • Height: 13 Millimeter
  • Width: 10 Millimeter
LS-397-1305

  • Spinal implant trial

Tx™ - M711LS39712120

Ti 6Al 4V (ELI)
Innovasis, Inc.
LS-397-1212
In Commercial Distribution

  • M711LS39712120 ()

  • Angle: 12.5 degree
  • Length: 28 Millimeter
  • Height: 12 Millimeter
  • Width: 10 Millimeter
LS-397-1212

  • Spinal implant trial

Tx™ - M711LS39712100

Ti 6Al 4V (ELI)
Innovasis, Inc.
LS-397-1210
In Commercial Distribution

  • M711LS39712100 ()

  • Angle: 10 degree
  • Length: 28 Millimeter
  • Height: 12 Millimeter
  • Width: 10 Millimeter
LS-397-1210

  • Spinal implant trial

Tx™ - M711LS39712050

Ti 6Al 4V (ELI)
Innovasis, Inc.
LS-397-1205
In Commercial Distribution

  • M711LS39712050 ()

  • Angle: 5 degree
  • Length: 28 Millimeter
  • Height: 12 Millimeter
  • Width: 10 Millimeter
LS-397-1205

  • Spinal implant trial

Tx™ - M711LS39711120

Ti 6Al 4V (ELI)
Innovasis, Inc.
LS-397-1112
In Commercial Distribution

  • M711LS39711120 ()

  • Angle: 12.5 degree
  • Length: 28 Millimeter
  • Height: 11 Millimeter
  • Width: 10 Millimeter
LS-397-1112

  • Spinal implant trial

Tx™ - M711LS39711100

Ti 6Al 4V (ELI)
Innovasis, Inc.
LS-397-1110
In Commercial Distribution

  • M711LS39711100 ()

  • Angle: 10 degree
  • Length: 28 Millimeter
  • Height: 11 Millimeter
  • Width: 10 Millimeter
LS-397-1110

  • Spinal implant trial

Tx™ - M711LS39711050

Ti 6Al 4V (ELI)
Innovasis, Inc.
LS-397-1105
In Commercial Distribution

  • M711LS39711050 ()

  • Angle: 5 degree
  • Length: 28 Millimeter
  • Height: 11 Millimeter
  • Width: 10 Millimeter
LS-397-1105

  • Spinal implant trial

Tx™ - M711LS39710120

Ti 6Al 4V (ELI)
Innovasis, Inc.
LS-397-1012
In Commercial Distribution

  • M711LS39710120 ()

  • Angle: 12.5 degree
  • Length: 28 Millimeter
  • Height: 10 Millimeter
  • Width: 10 Millimeter
LS-397-1012

  • Spinal implant trial

Tx™ - M711LS39710100

Ti 6Al 4V (ELI)
Innovasis, Inc.
LS-397-1010
In Commercial Distribution

  • M711LS39710100 ()

  • Angle: 10 degree
  • Length: 28 Millimeter
  • Height: 10 Millimeter
  • Width: 10 Millimeter
LS-397-1010

  • Spinal implant trial

Tx™ - M711LS39710050

Ti 6Al 4V (ELI)
Innovasis, Inc.
LS-397-1005
In Commercial Distribution

  • M711LS39710050 ()

  • Angle: 5 degree
  • Length: 28 Millimeter
  • Height: 10 Millimeter
  • Width: 10 Millimeter
LS-397-1005

  • Spinal implant trial
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