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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 Class Implantable

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PathLoc- SI Joint Fusion System - 08800061393767

Arch Screw (Bullet Type)
L&K BIOMED CO. ,LTD.
1024-2040
In Commercial Distribution

  • 08800061393767 ()
1024-2040

  • Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

PathLoc- SI Joint Fusion System - 08800061393743

Arch Screw (Bullet Type)
L&K BIOMED CO. ,LTD.
1024-2030
In Commercial Distribution

  • 08800061393743 ()
1024-2030

  • Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

AccelFix Spinal Fixation System - 08800061327618

Reduction Poly Axial Screw Ø5.5 , 55mm
L&K BIOMED CO. ,LTD.
8104-5555S
In Commercial Distribution

  • 08800061327618 ()


  • Spinal bone screw, non-bioabsorbable

AccelFix Spinal Fixation System - 08800061325317

Reduction Mono Axial Screw Ø8.5 , 75mm
L&K BIOMED CO. ,LTD.
8102-8575S
In Commercial Distribution

  • 08800061325317 ()


  • Spinal bone screw, non-bioabsorbable

AccelFix Spinal Fixation System - 08800061323696

Reduction Mono Axial Screw Ø4.0 , 30mm
L&K BIOMED CO. ,LTD.
8102-4030S
In Commercial Distribution

  • 08800061323696 ()


  • Spinal bone screw, non-bioabsorbable

AccelFix Spinal Fixation System - 08800061325843

Poly Axial Screw Ø6.0 , 25mm
L&K BIOMED CO. ,LTD.
8103-6025S
In Commercial Distribution

  • 08800061325843 ()


  • Cannulated surgical drill bit, single-use

AccelFix Spinal Fixation System - 08800061325836

Poly Axial Screw Ø6.0 , 20mm
L&K BIOMED CO. ,LTD.
8103-6020S
In Commercial Distribution

  • 08800061325836 ()


  • Spinal bone screw, non-bioabsorbable

AccelFix Spinal Fixation System - 08800061324891

Reduction Mono Axial Screw Ø7.5 , 135mm
L&K BIOMED CO. ,LTD.
8102-75135S
In Commercial Distribution

  • 08800061324891 ()


  • Spinal bone screw, non-bioabsorbable

AccelFix Spinal Fixation System - 08800061322057

Mono Axial Screw Ø5.0 , 20mm
L&K BIOMED CO. ,LTD.
8101-5020S
In Commercial Distribution

  • 08800061322057 ()


  • Spinal bone screw, non-bioabsorbable

AccelFix Spinal Fixation System - 08800061318401

Percutaneous Poly Screw Open Type Ø7.5 , 60mm
L&K BIOMED CO. ,LTD.
2305-7560
In Commercial Distribution

  • 08800061318401 ()
2305-7560

  • Spinal bone screw, non-bioabsorbable
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