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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 - 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

KneeAlign 2 - 00858704006381

KneeAlign 2 Instrument Tray Base
Orthalign, Inc.
402066-1
In Commercial Distribution

  • 00858704006381 ()
402066-1

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006374

2.5mm Ball Driver
Orthalign, Inc.
402048
In Commercial Distribution

  • 00858704006374 ()
402048

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006367

KneeAlign 2 Mounting Bracket
Orthalign, Inc.
402046
In Commercial Distribution

  • 00858704006367 ()
402046

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006343

Distal Guide Assembly
Orthalign, Inc.
402043
In Commercial Distribution

  • 00858704006343 ()
402043

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00858704006336

MicroBlock Assembly
Orthalign, Inc.
402042
In Commercial Distribution

  • 00858704006336 ()
402042

  • Orthopaedic surgical procedure kit, non-medicated, reusable

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
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