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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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Reform POCT System - 00840019927154

Add-on Instrument Sterilization Case
PRECISION SPINE, INC.
55-SC-0203
In Commercial Distribution

  • 00840019927154 ()
55-SC-0203

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform POCT System - 00840019927017

Occipital Instrument Sterilization Case
PRECISION SPINE, INC.
55-SC-0202
In Commercial Distribution

  • 00840019927017 ()
55-SC-0202

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform POCT System - 00840019927000

Standard Instrument Sterilization Case
PRECISION SPINE, INC.
55-SC-0201
In Commercial Distribution

  • 00840019927000 ()
55-SC-0201

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform POCT System - 00840019926997

Occipital Implant Sterilization Case
PRECISION SPINE, INC.
55-SC-0103
In Commercial Distribution

  • 00840019926997 ()
55-SC-0103

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform POCT System - 00840019926980

Add-on Implant Sterilization Case
PRECISION SPINE, INC.
55-SC-0102
In Commercial Distribution

  • 00840019926980 ()
55-SC-0102

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform POCT System - 00840019926973

Standard Implant Sterilization Case
PRECISION SPINE, INC.
55-SC-0101
In Commercial Distribution

  • 00840019926973 ()
55-SC-0101

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Accufit Lateral Plate System - 00840019919876

AccuFit® LP Case
PRECISION SPINE, INC.
58-SC-1000
In Commercial Distribution

  • 00840019919876 ()
58-SC-1000

  • Orthopaedic surgical procedure kit, non-medicated, reusable

MD Vue Lateral Access - 00840019919692

Table Arm Case (Empty)
PRECISION SPINE, INC.
54-SC-2000
In Commercial Distribution

  • 00840019919692 ()
54-SC-2000

  • Orthopaedic surgical procedure kit, non-medicated, reusable

MD Vue Discectomy - 00840019918893

0° Implant Case (Empty)
PRECISION SPINE, INC.
60-SC-6000
In Commercial Distribution

  • 00840019918893 ()
60-SC-6000

  • Orthopaedic surgical procedure kit, non-medicated, reusable

MD Vue Discectomy - 00840019918862

7° Implant Case (Empty)
PRECISION SPINE, INC.
60-SC-5000
In Commercial Distribution

  • 00840019918862 ()
60-SC-5000

  • Orthopaedic surgical procedure kit, non-medicated, reusable

MD Vue Discectomy - 00840019918855

Angled Instruments Case (Empty)
PRECISION SPINE, INC.
60-SC-4000
In Commercial Distribution

  • 00840019918855 ()
60-SC-4000

  • Orthopaedic surgical procedure kit, non-medicated, reusable

MD Vue Discectomy - 00840019918831

Implantation Instruments Case (Empty)
PRECISION SPINE, INC.
60-SC-2000
In Commercial Distribution

  • 00840019918831 ()
60-SC-2000

  • Orthopaedic surgical procedure kit, non-medicated, reusable

MD Vue Discectomy - 00840019918824

Cobbs / Curettes Case (Empty)
PRECISION SPINE, INC.
60-SC-1000
In Commercial Distribution

  • 00840019918824 ()
60-SC-1000

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Vault C ACDF System - 00840019917247

Adjunct Rasp Sterilization Case
PRECISION SPINE, INC.
37-SC-0202
In Commercial Distribution

  • 00840019917247 ()
37-SC-0202

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Matrixx System - 00889929038772

Anterolateral Disc Prep, Case
NEXXT SPINE, LLC
C62-01-02
In Commercial Distribution

  • 00889929038772 ()


  • Device sterilization/disinfection container, reusable

Inertia® Pedicle Screw System - 00889929018569

Inertia Rod Manipulation Case
NEXXT SPINE, LLC
C10-01-16
In Commercial Distribution

  • 00889929018569 ()


  • Device sterilization/disinfection container, reusable

Inertia® Pedicle Screw System - 00889929018477

Inertia Rod Manipulation Case
NEXXT SPINE, LLC
C10-01-02
In Commercial Distribution

  • 00889929018477 ()


  • Device sterilization/disinfection container, reusable

Inertia® Pedicle Screw System - 00889929018460

Inertia Screw Insertion Case
NEXXT SPINE, LLC
C10-01-01
In Commercial Distribution

  • 00889929018460 ()


  • Device sterilization/disinfection container, reusable

HONOUR™ Spacer System - 00889929017227

Honour Cervical Interbody Case
NEXXT SPINE, LLC
C35-01-01
In Commercial Distribution

  • 00889929017227 ()


  • Device sterilization/disinfection container, reusable

HONOUR™ Spacer System - 00889929017180

Honour Disc Preparation Case
NEXXT SPINE, LLC
C21-02-02
In Commercial Distribution

  • 00889929017180 ()


  • Device sterilization/disinfection container, reusable
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