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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MESA 2 Hemi-Polyaxial Screw, Size Ø6.5X70 mm
K2M, INC.
6201-P6570
In Commercial Distribution

  • 10888857274976 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 70 Millimeter
6201-P6570

  • Bone-screw internal spinal fixation system, non-sterile
MESA 2 Hemi-Polyaxial Screw, Size Ø6.5X65 mm
K2M, INC.
6201-P6565
In Commercial Distribution

  • 10888857274969 ()

  • Length: 65 Millimeter
  • Outer Diameter: 6.5 Millimeter
6201-P6565

  • Bone-screw internal spinal fixation system, non-sterile
MESA 2 Hemi-Polyaxial Screw, Size Ø6.5X60 mm
K2M, INC.
6201-P6560
In Commercial Distribution

  • 10888857274952 ()

  • Length: 60 Millimeter
  • Outer Diameter: 6.5 Millimeter
6201-P6560

  • Bone-screw internal spinal fixation system, non-sterile
MESA 2 Hemi-Polyaxial Screw, Size Ø6.5X55 mm
K2M, INC.
6201-P6555
In Commercial Distribution

  • 10888857274945 ()

  • Length: 55 Millimeter
  • Outer Diameter: 6.5 Millimeter
6201-P6555

  • Bone-screw internal spinal fixation system, non-sterile
MESA 2 Hemi-Polyaxial Screw, Size Ø6.5X50 mm
K2M, INC.
6201-P6550
In Commercial Distribution

  • 10888857274938 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 50 Millimeter
6201-P6550

  • Bone-screw internal spinal fixation system, non-sterile
MESA 2 Hemi-Polyaxial Screw Size Dia. 6.5X45 mm
K2M, INC.
6201-P6545
In Commercial Distribution

  • 10888857274921 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 45 Millimeter
6201-P6545

  • Bone-screw internal spinal fixation system, non-sterile
MESA 2 Hemi-Polyaxial Screw Size Dia. 6.5X40 mm
K2M, INC.
6201-P6540
In Commercial Distribution

  • 10888857274914 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 40 Millimeter
6201-P6540

  • Bone-screw internal spinal fixation system, non-sterile
MESA 2 Hemi-Polyaxial Screw Size Dia. 6.5X35 mm
K2M, INC.
6201-P6535
In Commercial Distribution

  • 10888857274907 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 35 Millimeter
6201-P6535

  • Bone-screw internal spinal fixation system, non-sterile
MESA 2 Hemi-Polyaxial Screw Size Dia. 6.5X30 mm
K2M, INC.
6201-P6530
In Commercial Distribution

  • 10888857274891 ()

  • Length: 30 Millimeter
  • Outer Diameter: 6.5 Millimeter
6201-P6530

  • Bone-screw internal spinal fixation system, non-sterile
The Pedicle Screw Spinal Fixation Systemconsists of a variety of shapes and sizes of rods, screws, and cross links which can be rigidly locked into a variety of configurations, made for the individual case.
BM KOREA CO., LTD
A1P1-6545
In Commercial Distribution

  • 08809255540673 ()

  • Length: 45 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
The Pedicle Screw Spinal Fixation Systemconsists of a variety of shapes and sizes of rods, screws, and cross links which can be rigidly locked into a variety of configurations, made for the individual case.
BM KOREA CO., LTD
A1P1-6540
In Commercial Distribution

  • 08809255540666 ()

  • Length: 40 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
The Pedicle Screw Spinal Fixation Systemconsists of a variety of shapes and sizes of rods, screws, and cross links which can be rigidly locked into a variety of configurations, made for the individual case.
BM KOREA CO., LTD
A1P1-6535
In Commercial Distribution

  • 08809255540659 ()

  • Length: 35 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
The GALAXY MIS Screw System is intended to provide immobilization and Stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
BM KOREA CO., LTD
GXMS-6560
In Commercial Distribution

  • 08809255540154 ()

  • Length: 60 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
The GALAXY MIS Screw System is intended to provide immobilization and Stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
BM KOREA CO., LTD
GXMS-6550
In Commercial Distribution

  • 08809255540130 ()

  • Length: 50 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
The GALAXY MIS Screw System is intended to provide immobilization and Stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
BM KOREA CO., LTD
GXMS-6545
In Commercial Distribution

  • 08809255540123 ()

  • Length: 45 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
The GALAXY MIS Screw System is intended to provide immobilization and Stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
BM KOREA CO., LTD
GXMS-6530
In Commercial Distribution

  • 08809255540093 ()

  • Length: 30 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Endosseous dental implant abutment
Dentium Co., Ltd.
DAB6555HT
In Commercial Distribution

  • 08809162708432 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 13.7 Millimeter
DAB6555HT

  • Dental implant suprastructure, permanent, preformed
Endosseous dental implant abutment
Dentium Co., Ltd.
DAB6545HT
In Commercial Distribution

  • 08809162708425 ()

  • Length: 12.7 Millimeter
  • Outer Diameter: 6.5 Millimeter
DAB6545HT

  • Dental implant suprastructure, permanent, preformed
Endosseous dental implant abutment
Dentium Co., Ltd.
DAB6535HT
In Commercial Distribution

  • 08809162708418 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 11.7 Millimeter
DAB6535HT

  • Dental implant suprastructure, permanent, preformed
Endosseous dental implant abutment
Dentium Co., Ltd.
DAB6525HT
In Commercial Distribution

  • 08809162708401 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 10.7 Millimeter
DAB6525HT

  • Dental implant suprastructure, permanent, preformed
Endosseous dental implant abutment
Dentium Co., Ltd.
DAB6515HT
In Commercial Distribution

  • 08809162708395 ()

  • Length: 9.7 Millimeter
  • Outer Diameter: 6.5 Millimeter
DAB6515HT

  • Dental implant suprastructure, permanent, preformed
Endosseous dental implant abutment
Dentium Co., Ltd.
DAB65358HT
In Commercial Distribution

  • 08809162708258 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 14.7 Millimeter
DAB65358HT

  • Dental implant suprastructure, permanent, preformed
Endosseous dental implant abutment
Dentium Co., Ltd.
DAB65258HT
In Commercial Distribution

  • 08809162708241 ()

  • Length: 14.7 Millimeter
  • Outer Diameter: 6.5 Millimeter
DAB65258HT

  • Dental implant suprastructure, permanent, preformed
Endosseous dental implant abutment
Dentium Co., Ltd.
DAB65158HT
In Commercial Distribution

  • 08809162708234 ()

  • Length: 14.7 Millimeter
  • Outer Diameter: 6.5 Millimeter
DAB65158HT

  • Dental implant suprastructure, permanent, preformed
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
XPP162265
In Commercial Distribution

  • 08809162706599 ()

  • Length: 21.5 Millimeter
  • Outer Diameter: 6.5 Millimeter
XPP162265

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
SOSRG65
In Commercial Distribution

  • 08809162706292 ()

  • Outer Diameter: 6.5 Millimeter
SOSRG65

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
SOSBC6516N
In Commercial Distribution

  • 08809162706216 ()

  • Length: 12 Millimeter
  • Outer Diameter: 6.5 Millimeter
SOSBC6516N

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
SOSBC6516H
In Commercial Distribution

  • 08809162706209 ()

  • Length: 12 Millimeter
  • Outer Diameter: 6.5 Millimeter
SOSBC6516H

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
SODTF6568O
In Commercial Distribution

  • 08809162706148 ()

  • Outer Diameter: 6.5 Millimeter
SODTF6568O

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
SODTF6568N
In Commercial Distribution

  • 08809162706131 ()

  • Outer Diameter: 6.5 Millimeter
SODTF6568N

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
SODPU6568O
In Commercial Distribution

  • 08809162706100 ()

  • Outer Diameter: 6.5 Millimeter
SODPU6568O

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
SODPU6568N
In Commercial Distribution

  • 08809162706094 ()

  • Outer Diameter: 6.5 Millimeter
SODPU6568N

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
SODIC65
In Commercial Distribution

  • 08809162706056 ()

  • Length: 10.8 Millimeter
  • Outer Diameter: 6.5 Millimeter
SODIC65

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
SODBC65S
In Commercial Distribution

  • 08809162706032 ()

  • Length: 12.8 Millimeter
  • Outer Diameter: 6.5 Millimeter
SODBC65S

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
SODBC65B
In Commercial Distribution

  • 08809162706025 ()

  • Length: 12.8 Millimeter
  • Outer Diameter: 6.5 Millimeter
SODBC65B

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
SODAN65
In Commercial Distribution

  • 08809162705998 ()

  • Outer Diameter: 6.5 Millimeter
SODAN65

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
SOCAN6570P
In Commercial Distribution

  • 08809162705950 ()

  • Outer Diameter: 6.5 Millimeter
SOCAN6570P

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
SOCAN6555P
In Commercial Distribution

  • 08809162705943 ()

  • Outer Diameter: 6.5 Millimeter
SOCAN6555P

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
SOCAN6540P
In Commercial Distribution

  • 08809162705936 ()

  • Outer Diameter: 6.5 Millimeter
SOCAN6540P

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
DTF6515NL
In Commercial Distribution

  • 08809162703543 ()

  • Outer Diameter: 6.5 Millimeter
DTF6515NL

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
DTF6515HL
In Commercial Distribution

  • 08809162703536 ()

  • Outer Diameter: 6.5 Millimeter
DTF6515HL

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
DTF6511NL
In Commercial Distribution

  • 08809162703529 ()

  • Outer Diameter: 6.5 Millimeter
DTF6511NL

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
DTF6511HL
In Commercial Distribution

  • 08809162703512 ()

  • Outer Diameter: 6.5 Millimeter
DTF6511HL

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
DPU6515NL
In Commercial Distribution

  • 08809162703383 ()

  • Outer Diameter: 6.5 Millimeter
DPU6515NL

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
DPU6515HL
In Commercial Distribution

  • 08809162703376 ()

  • Outer Diameter: 6.5 Millimeter
DPU6515HL

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
DPU6511NL
In Commercial Distribution

  • 08809162703369 ()

  • Outer Diameter: 6.5 Millimeter
DPU6511NL

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
DPU6511HL
In Commercial Distribution

  • 08809162703352 ()

  • Outer Diameter: 6.5 Millimeter
DPU6511HL

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
CRG65L
In Commercial Distribution

  • 08809162703123 ()

  • Outer Diameter: 6.5 Millimeter
CRG65L

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
CIC65L(1)
In Commercial Distribution

  • 08809162703055 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 1.4 Millimeter
CIC65L

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
CBC65SL(1)
In Commercial Distribution

  • 08809162702980 ()

  • Length: 12.8 Millimeter
  • Outer Diameter: 6.5 Millimeter
CBC65SL

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
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