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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 - 00851977007987

Metal Instrument Tray, 10x10
Orthalign, Inc.
402073
In Commercial Distribution

  • 00851977007987 ()
402073

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00851977007970

Base, Tray, 10x10
Orthalign, Inc.
402073-1
In Commercial Distribution

  • 00851977007970 ()
402073-1

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00851977007925

Reference Sensor 5 Knee (RS5K)
Orthalign, Inc.
133632-06
In Commercial Distribution

  • 00851977007925 ()
133632-06

  • Orthopaedic stereotactic surgery system

KneeAlign 2 - 00851977007475

Calf Spring, 165mm
Orthalign, Inc.
401500
In Commercial Distribution

  • 00851977007475 ()
401500

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00851977007468

Probe, Midline, Low-Profile, Left
Orthalign, Inc.
401645
In Commercial Distribution

  • 00851977007468 ()
401645

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00851977007451

Probe, Midline, Low-Profile, Right
Orthalign, Inc.
401644
In Commercial Distribution

  • 00851977007451 ()
401644

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00851977007307

Resection Stylus, Adjustable, Captured, Low Clearance
Orthalign, Inc.
401639
In Commercial Distribution

  • 00851977007307 ()
401639

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00851977007291

KneeAlign 2 Tibial Jig Body, Reduced Length
Orthalign, Inc.
401641
In Commercial Distribution

  • 00851977007291 ()
401641

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00851977007284

Ankle Tube, Reduced Length
Orthalign, Inc.
401640
In Commercial Distribution

  • 00851977007284 ()
401640

  • Orthopaedic surgical procedure kit, non-medicated, reusable

KneeAlign 2 - 00851977007246

Narrow Distal Guide
Orthalign, Inc.
402441
In Commercial Distribution

  • 00851977007246 ()
402441

  • Orthopaedic surgical procedure kit, non-medicated, reusable
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