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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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Gibralt® - M711PC1400

POSTERIOR CERVICAL,HOOK HOLDER, SST, Medcoat 2000
Innovasis, Inc.
PC-140
In Commercial Distribution

  • M711PC1400 ()


  • Orthopaedic implant driver

Gibralt® - M711PC1190

POSTERIOR CERVICAL,SET SCREW DRIVER, T15, SST, Tin, Medcoat 2000
Innovasis, Inc.
PC-119
In Commercial Distribution

  • M711PC1190 ()


  • Orthopaedic implant driver

FixxSure - M711201160

FixxSure Cross Link Hex Driver, SST, Radel
Innovasis, Inc.
20116
In Commercial Distribution

  • M711201160 ()


  • Orthopaedic implant driver

Silex Sacroiliac Joint Fusion System - M697X07900601

12.5mm IMPLANT DRIVER ASSY, CANNULATED
Xtant Medical Holdings, Inc.
X079-0060
In Commercial Distribution

  • M697X07900600 ()
  • M697X07900601 ()

  • Outer Diameter: 12.5 Millimeter


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

Silex Sacroiliac Joint Fusion System - M697X07900331

7mm ADJUSTMENT IMPLANT DRIVER, CANNULATED
Xtant Medical Holdings, Inc.
X079-0033
In Commercial Distribution

  • M697X07900330 ()
  • M697X07900331 ()

  • Outer Diameter: 7 Millimeter


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

Silex Sacroiliac Joint Fusion System - M697X07900301

7mm IMPLANT DRIVER ASSY, CANNULATED
Xtant Medical Holdings, Inc.
X079-0030
In Commercial Distribution

  • M697X07900300 ()
  • M697X07900301 ()

  • Outer Diameter: 7 Millimeter


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

Certex Spinal Fixation System - M697X06708051

TORQUE DRIVER T-HANDLE, 1/4" SQUARE CONNECT
Xtant Medical Holdings, Inc.
X067-0805
Not in Commercial Distribution

  • M697X06708050 ()
  • M697X06708051 ()


  • Surgical instrument handle, torque-limiting

Certex Spinal Fixation System - M697X06704251

CROSS CONNECTOR LOCKING DRIVER
Xtant Medical Holdings, Inc.
X067-0425
Not in Commercial Distribution

  • M697X06704250 ()
  • M697X06704251 ()


  • Surgical screwdriver, reusable

Fortex Pedicle Screw System - M697X06401401

Reduction Pedicle Screwdriver Assembly
Xtant Medical Holdings, Inc.
X064-0140
In Commercial Distribution

  • M697X06401400 ()
  • M697X06401401 ()


  • Surgical screwdriver, reusable

Fortex Pedicle Screw System - M697X07000451

Torque Driver Handle, 30 in-lbs
Xtant Medical Holdings, Inc.
X070-0045
In Commercial Distribution

  • M697X07000450 ()
  • M697X07000451 ()


  • Surgical instrument handle, torque-limiting
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