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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 - 00858704006510

Button Cap, Black
Orthalign, Inc.
402047-03
In Commercial Distribution

  • 00858704006510 ()
402047-03

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006503

Button Cap, White
Orthalign, Inc.
402046-08
In Commercial Distribution

  • 00858704006503 ()
402046-08

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006480

Femoral Drill Guide, Neutral
Orthalign, Inc.
402418
In Commercial Distribution

  • 00858704006480 ()
402418

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006459

Threaded Pin, Headless, 65mm
Orthalign, Inc.
402069
In Commercial Distribution

  • 00858704006459 ()
  • 00851977007161 ()
402069

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006442

Threaded Pin, Headed, 46mm
Orthalign, Inc.
402068
In Commercial Distribution

  • 00858704006442 ()
  • 00851977007178 ()
402068

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006435

Pin Driver, Tri-Flat, 3.2mm
Orthalign, Inc.
403189
In Commercial Distribution

  • 00858704006435 ()
403189

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006428

Pin Driver
Orthalign, Inc.
402067
In Commercial Distribution

  • 00858704006428 ()
402067

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006411

KneeAlign 2 Instrument Tray Base
Orthalign, Inc.
402066-4
In Commercial Distribution

  • 00858704006411 ()
402066-4

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006404

KneeAlign 2 Inner Tray
Orthalign, Inc.
402066-3
In Commercial Distribution

  • 00858704006404 ()
402066-3

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006398

Instrument Tray Lid
Orthalign, Inc.
402066-2
In Commercial Distribution

  • 00858704006398 ()
402066-2

  • Orthopaedic surgical procedure kit, non-medicated, reusable
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