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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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iTotal® Patella Sizer - 00850268007132

iTotal® 29mm Patella Sizer Reusable Instrument
Conformis, Inc.
1080-528
In Commercial Distribution

  • 00850268007132 ()

  • Outer Diameter: 29 Millimeter


  • Orthopaedic prosthesis implantation positioning instrument, reusable
  • Patella prosthesis trial

iTotal® Patella Trial - 00850268007125

iTotal® 41mm Patella Trial Reusable Instrument
Conformis, Inc.
1080-513
In Commercial Distribution

  • 00850268007125 ()

  • Outer Diameter: 41 Millimeter


  • Patella prosthesis trial

iTotal® Patella Trial - 00850268007118

iTotal® 38mm Patella Trial Reusable Instrument
Conformis, Inc.
1080-512
In Commercial Distribution

  • 00850268007118 ()

  • Outer Diameter: 38 Millimeter


  • Patella prosthesis trial

iTotal® Patella Trial - 00850268007101

iTotal® 35mm Patella Trial Reusable Instrument
Conformis, Inc.
1080-511
In Commercial Distribution

  • 00850268007101 ()

  • Outer Diameter: 35 Millimeter


  • Patella prosthesis trial

iTotal® Patella Trial - 00850268007095

iTotal® 32mm Patella Trial Reusable Instrument
Conformis, Inc.
1080-510
In Commercial Distribution

  • 00850268007095 ()

  • Outer Diameter: 32 Millimeter


  • Patella prosthesis trial

iTotal® Patella Trial - 00850268007088

iTotal® 29mm Patella Trial Reusable Instrument
Conformis, Inc.
1080-509
In Commercial Distribution

  • 00850268007088 ()

  • Outer Diameter: 29 Millimeter


  • Patella prosthesis trial

NA - 00850231007992

8mm Shaver
Integrity Implants Inc.
II-1-0319
In Commercial Distribution

  • 00850231007992 ()
II-1-0319

  • Bone file/rasp, manual, reusable

NA - 00850231007985

7mm Shaver
Integrity Implants Inc.
II-1-0318
In Commercial Distribution

  • 00850231007985 ()
II-1-0318

  • Bone file/rasp, manual, reusable

FlareHawk - 00850231007978

15mm Paddle Distractor
Integrity Implants Inc.
II-1-0317
In Commercial Distribution

  • 00850231007978 ()
II-1-0317

  • Orthopaedic surgical distractor, internal

NA - 00850231007961

14mm Paddle Distractor
Integrity Implants Inc.
II-1-0316
In Commercial Distribution

  • 00850231007961 ()
II-1-0316

  • Orthopaedic surgical distractor, internal
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