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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MESH 9051790 PYRM IMPL 17MMX22MMX90MM
MEDTRONIC SOFAMOR DANEK, INC.
9051790
In Commercial Distribution

  • 00681490484596 ()

  • 17mm x 22mm x 90mm OVOID


  • Vertebral body prosthesis
No Description
Biomet Orthopedics, LLC
31-473056
In Commercial Distribution

  • 00880304003064 ()
31-473056

  • Femoral head prosthesis trial
No Description
Biomet Orthopedics, LLC
31-473155
In Commercial Distribution

  • 00880304003057 ()
31-473155

  • Femoral head prosthesis trial
No Description
Biomet Orthopedics, LLC
31-473154
In Commercial Distribution

  • 00880304003040 ()
31-473154

  • Femoral head prosthesis trial
No Description
Biomet Orthopedics, LLC
31-473156
In Commercial Distribution

  • 00880304003033 ()
31-473156

  • Femoral head prosthesis trial
No Description
Biomet Orthopedics, LLC
31-473053
In Commercial Distribution

  • 00880304003026 ()
31-473053

  • Femoral head prosthesis trial
No Description
Biomet Orthopedics, LLC
31-473051
In Commercial Distribution

  • 00880304003019 ()
31-473051

  • Femoral head prosthesis trial
No Description
Biomet Orthopedics, LLC
31-473052
In Commercial Distribution

  • 00880304003002 ()
31-473052

  • Femoral head prosthesis trial
No Description
Biomet Orthopedics, LLC
31-473054
In Commercial Distribution

  • 00880304002999 ()
31-473054

  • Femoral head prosthesis trial
No Description
Biomet Orthopedics, LLC
31-473050
In Commercial Distribution

  • 00880304002982 ()
31-473050

  • Femoral head prosthesis trial
No Description
Biomet Orthopedics, LLC
11-108275
In Commercial Distribution

  • 00880304002951 ()

  • 15 SIZE 250 MM
11-108275

  • Acetabular shell
No Description
Biomet Orthopedics, LLC
11-103552
In Commercial Distribution

  • 00880304002944 ()

  • 52 MM 23 LINER SIZE
11-103552

  • Acetabular shell
MESH 9051770 PYRAMESH 17MMX22MMX70MM
MEDTRONIC SOFAMOR DANEK, INC.
9051770
In Commercial Distribution

  • 00681490484589 ()

  • 17mm x 22mm x 70mm OVOID


  • Vertebral body prosthesis
MESH 9051750 PYRAMESH 17MMX22MMX50MM
MEDTRONIC SOFAMOR DANEK, INC.
9051750
In Commercial Distribution

  • 00681490484572 ()

  • 17mm x 22mm x 50mm OVOID


  • Vertebral body prosthesis
PYRAMESH IMPL 17MMX22MMX30MM
MEDTRONIC SOFAMOR DANEK, INC.
9051730
In Commercial Distribution

  • 00681490484565 ()

  • 17mm x 22mm x 30mm OVOID


  • Vertebral body prosthesis
MESH 9051690 PYRM IMPLANT 16MMX90MM RND
MEDTRONIC SOFAMOR DANEK, INC.
9051690
In Commercial Distribution

  • 00681490484527 ()

  • 16mm x 90mm ROUND


  • Vertebral body prosthesis
MESH 9051350 PYRAMESH IMP 13MMX50MM RND
MEDTRONIC SOFAMOR DANEK, INC.
9051350
In Commercial Distribution

  • 00681490484510 ()

  • 13mm x 50mm


  • Vertebral body prosthesis
PYRAMESH TALL IMPLANT CASE
MEDTRONIC SOFAMOR DANEK, INC.
9050899
In Commercial Distribution

  • 00681490484374 ()


  • Instrument tray, reusable
PYRAMESH TALL C IMPLANT CASE
MEDTRONIC SOFAMOR DANEK, INC.
9050898
In Commercial Distribution

  • 00681490484367 ()


  • Instrument tray, reusable
PYRAMESH A TRAY
MEDTRONIC SOFAMOR DANEK, INC.
9050897
In Commercial Distribution

  • 00681490484350 ()


  • Instrument tray, reusable
CASE 9050896 PYRM SHORT IMPL OVOID
MEDTRONIC SOFAMOR DANEK, INC.
9050896
In Commercial Distribution

  • 00681490484343 ()


  • Instrument tray, reusable
MESH 9050725 PYMSH IMPL 25MM END CAP
MEDTRONIC SOFAMOR DANEK, INC.
9050725
In Commercial Distribution

  • 00681490484299 ()

  • 25mm


  • Vertebral body prosthesis
MESH 9050722 PYMSH IMPL 22MM END CAP
MEDTRONIC SOFAMOR DANEK, INC.
9050722
In Commercial Distribution

  • 00681490484282 ()

  • 22mm


  • Vertebral body prosthesis
MESH 9050719 PYMSH IMPL 19MM END CAP
MEDTRONIC SOFAMOR DANEK, INC.
9050719
In Commercial Distribution

  • 00681490484275 ()

  • 19mm


  • Vertebral body prosthesis
MESH 9050716 PYMSH IMPL 16MM END CAP
MEDTRONIC SOFAMOR DANEK, INC.
9050716
In Commercial Distribution

  • 00681490484268 ()

  • 16mm


  • Vertebral body prosthesis
MESH 9050713 PYMSH IMPL 13MM END CAP
MEDTRONIC SOFAMOR DANEK, INC.
9050713
In Commercial Distribution

  • 00681490484251 ()

  • 13mm


  • Vertebral body prosthesis
INSTRUMENT 9050700 PYMSH END CAP INSERT
MEDTRONIC SOFAMOR DANEK, INC.
9050700
In Commercial Distribution

  • 00681490484244 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
MESH 9050450 PYRAMESH IMP 10MMX14MMX50MM
MEDTRONIC SOFAMOR DANEK, INC.
9050450
In Commercial Distribution

  • 00681490484213 ()

  • 10mm x 14mm x 50mm


  • Vertebral body prosthesis
16MM RP INNER TRAY
MEDTRONIC SOFAMOR DANEK, INC.
901-917
Not in Commercial Distribution

  • 00681490483889 ()


  • Instrument tray, reusable
16MM RP BASE CASE
MEDTRONIC SOFAMOR DANEK, INC.
901-916
Not in Commercial Distribution

  • 00681490483872 ()


  • Instrument tray, reusable
DISTRACTOR 901-651 C-STYLE 16/10MM
MEDTRONIC SOFAMOR DANEK, INC.
901-651
Not in Commercial Distribution

  • 00681490483797 ()


  • Orthopaedic surgical distractor, internal
INSTRUMENT 8616155 COLORADO 2 5.5MM TAP
MEDTRONIC SOFAMOR DANEK, INC.
8616155
In Commercial Distribution

  • 00681490483506 ()


  • Bone tap, reusable
HEX DRIVER 8081532R REFURBISHED 3/8 INCH
MEDTRONIC SOFAMOR DANEK, INC.
8081532R
In Commercial Distribution

  • 00681490482790 ()

  • 3/8"


  • Surgical screwdriver, reusable
INSTRUMENT 80615513B LONG TRAUMA CMPRSSR
MEDTRONIC SOFAMOR DANEK, INC.
80615513B
In Commercial Distribution

  • 00681490482776 ()


  • Orthopaedic surgical distractor, internal
INSTRUMENT 6860484 LOCKSCREW DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
6860484
In Commercial Distribution

  • 00681490482660 ()


  • Surgical screwdriver, reusable
INSTRUMENT 6860482 SCREWDRIVER
MEDTRONIC SOFAMOR DANEK, INC.
6860482
In Commercial Distribution

  • 00681490482653 ()


  • Surgical screwdriver, reusable
INSTRUMENT 6860472 4.0 X 13MM TAP
MEDTRONIC SOFAMOR DANEK, INC.
6860472
In Commercial Distribution

  • 00681490482622 ()

  • 4.0 x 13mm


  • Bone tap, reusable
INSTRUMENT 6860470 DRILL BIT HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
6860470
In Commercial Distribution

  • 00681490482615 ()


  • Fluted surgical drill bit, reusable
No Description
Biomet Orthopedics, LLC
141513
In Commercial Distribution

  • 00880304002920 ()

  • 71 MM
141513

  • Uncoated knee tibia prosthesis, metallic
No Description
Biomet Orthopedics, LLC
141512
In Commercial Distribution

  • 00880304002913 ()

  • 67 MM
141512

  • Uncoated knee tibia prosthesis, metallic
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