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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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KneeAlign 2 - 00858704006329

Universal Tibial Cutting Block
Orthalign, Inc.
401612
In Commercial Distribution

  • 00858704006329 ()
401612

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006312

Reversed Tibial Cutting Block, Right
Orthalign, Inc.
401610
In Commercial Distribution

  • 00858704006312 ()
401610

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006305

Reversed Tibial Cutting Block, Left
Orthalign, Inc.
401609
In Commercial Distribution

  • 00858704006305 ()
401609

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006299

KneeAlign 2 Tibial Jig Body
Orthalign, Inc.
402049
In Commercial Distribution

  • 00858704006299 ()
402049

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006282

KneeAlign 2 Tibial Jig Body, Streamlined
Orthalign, Inc.
401616
In Commercial Distribution

  • 00858704006282 ()
401616

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006275

KneeAlign 2 Tibial Jig Body
Orthalign, Inc.
401594
In Commercial Distribution

  • 00858704006275 ()
401594

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006268

Calf Strap
Orthalign, Inc.
401592
In Commercial Distribution

  • 00858704006268 ()
401592

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006251

Extended Tibial Cutting Block, Right
Orthalign, Inc.
401591
In Commercial Distribution

  • 00858704006251 ()
401591

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006244

Extended Tibial Cutting Block, Left
Orthalign, Inc.
401590
In Commercial Distribution

  • 00858704006244 ()
401590

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006237

Adjustable Resection Stylus
Orthalign, Inc.
401587
In Commercial Distribution

  • 00858704006237 ()
401587

  • Orthopaedic surgical procedure kit, non-medicated, reusable
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