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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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Aurora Spine - B5210010300

ZIP, INSTRUMENT CASE
AURORA SPINE, INC.
ZIP
In Commercial Distribution

  • B5210010300 ()
001-030

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

GLOBAL UNITE™ Short Stem Instrumentation - 00817766026423

SHORT HUMERAL CASE
SYMMETRY MEDICAL INC.
223600211
In Commercial Distribution

  • 00817766026423 ()


  • Device sterilization/disinfection container, reusable

Aurora Spine - B5211096000

EOS, INSTRUMENT CASE
AURORA SPINE, INC.
EOS
In Commercial Distribution

  • B5211096000 ()
109-600

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Aurora Spine - B5211086000

ECHO, INSTRUMENT CASE
AURORA SPINE, INC.
ECHO
In Commercial Distribution

  • B5211086000 ()
108-600

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Aurora Spine - B5211076000

VOX, INSTRUMENT CASE
AURORA SPINE, INC.
VOX
In Commercial Distribution

  • B5211076000 ()
107-600

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Aurora Spine - B5211066000

AFFINITY, INSTRUMENT CASE
AURORA SPINE, INC.
AFFINITY
In Commercial Distribution

  • B5211066000 ()
106-600

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Aurora Spine - B5211056000

DISCOVERY, INSTRUMENT CASE
AURORA SPINE, INC.
DISCOVERY
In Commercial Distribution

  • B5211056000 ()
105-600

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Smart Correction - B562SCSTR020

Strut Case Lid
Wishbone Medical, Inc.
SC-STR-02
Not in Commercial Distribution

  • B562SCSTR020 ()
SC-STR-02

  • Instrument tray, reusable

Smart Correction - B562SCSTR010

Strut Case Base
Wishbone Medical, Inc.
SC-STR-01
Not in Commercial Distribution

  • B562SCSTR010 ()
SC-STR-01

  • Instrument tray, reusable

Epiphany - B52810320

Disc Prep Case
PANTHEON SPINAL, LLC
1
In Commercial Distribution

  • B52810320 ()
103-2

  • General internal orthopaedic fixation system implantation kit

SILO - B5211136000

SILO, INSTRUMENT CASE
AURORA SPINE, INC.
113-600
In Commercial Distribution

  • B5211136000 ()


  • Instrument tray, reusable

Inertia® CONNEXX™ Modular Pedicle Screw System - 00889929058961

General Case, Tall
NEXXT SPINE, LLC
C92-01-11
In Commercial Distribution

  • 00889929058961 ()


  • Device sterilization/disinfection container, reusable

Inertia® CONNEXX™ Modular Pedicle Screw System - 00889929057964

General Case, 2-Tier
NEXXT SPINE, LLC
C92-01-10
In Commercial Distribution

  • 00889929057964 ()


  • Device sterilization/disinfection container, reusable

Struxxure® MCS Anterior Cervical System - 00889929055960

Struxxure MCS Case
NEXXT SPINE, LLC
C33-01-01
In Commercial Distribution

  • 00889929055960 ()


  • Device sterilization/disinfection container, reusable

Inertia® CONNEXX™ Modular Pedicle Screw System - 00889929054093

CONNEXX Revision Case
NEXXT SPINE, LLC
C20-01-09
In Commercial Distribution

  • 00889929054093 ()


  • Device sterilization/disinfection container, reusable

Inertia® Pedicle Screw System - 00889929050484

General Removal Case
NEXXT SPINE, LLC
C92-01-01
In Commercial Distribution

  • 00889929050484 ()


  • Device sterilization/disinfection container, reusable

HONOUR® Spacer System - 00889929043141

General Case, 1-Tier
NEXXT SPINE, LLC
C21-01-08
In Commercial Distribution

  • 00889929043141 ()


  • Device sterilization/disinfection container, reusable

Struxxure® Plate System - 00889929043059

Struxxure System Case
NEXXT SPINE, LLC
C63-01-01
In Commercial Distribution

  • 00889929043059 ()


  • Device sterilization/disinfection container, reusable

Matrixx System - 00889929046050

Lateral Trial Case
NEXXT SPINE, LLC
C62-01-08
In Commercial Distribution

  • 00889929046050 ()


  • Device sterilization/disinfection container, reusable

Inertia® Pedicle Screw and Deformity Correxxion® System - 00889929026175

General Case, Small
NEXXT SPINE, LLC
C21-01-07
In Commercial Distribution

  • 00889929026175 ()


  • Device sterilization/disinfection container, reusable

Matrixx System - 00889929039595

Lateral Instrument Case
NEXXT SPINE, LLC
C62-01-01
In Commercial Distribution

  • 00889929039595 ()


  • Device sterilization/disinfection container, reusable

Matrixx System - 00889929039588

ALIF Instrument Case
NEXXT SPINE, LLC
C60-01-01
In Commercial Distribution

  • 00889929039588 ()


  • Device sterilization/disinfection container, reusable

Matrixx System - 00889929038789

Lateral Access, Case
NEXXT SPINE, LLC
C62-01-03
In Commercial Distribution

  • 00889929038789 ()


  • Device sterilization/disinfection container, reusable

TRIGEN - 03596010648273

TRAUMA INTERFACE CASE
Smith & Nephew, Inc.
71692817
In Commercial Distribution

  • 03596010648273 ()
71692817

  • Instrument tray, reusable

CRW® - 10381780355731

CASE PS2 MODIFIED
INTEGRA LIFESCIENCES CORPORATION
S72901984
Not in Commercial Distribution

  • M248S729019841 ()
  • 10381780355731 ()


  • Stereotactic radiosurgical invasive head frame

KGTI™ Kinetik Great Toe Implant System - 10381780279761

KGTI STERILIZATION CASE
Ascension Orthopedics, Inc.
015001
Not in Commercial Distribution

  • M2480150011 ()
  • 10381780279761 ()
015001

  • Device sterilization/disinfection container, reusable

Cortium Universal OCT Spinal Fixation System - 00814386029049

Outer case lid
Ulrich Medical Usa, Inc.
UU000-00-01
In Commercial Distribution

  • 00814386029049 ()


  • Instrument tray, reusable

BUDDE® - 10381780255833

Halo Case Lid
INTEGRA LIFESCIENCES CORPORATION
438A1189
In Commercial Distribution

  • M268438A11891 ()
  • 10381780255833 ()


  • Neurosurgical retraction system, brain

Interspinous Plate System - 00815362022337

ISP Sterilization Case
PRECISION SPINE, INC.
29-6000
In Commercial Distribution

  • 00815362022337 ()
29-6000

  • Orthopaedic surgical procedure kit, non-medicated, reusable

RCS Anterior Buttress Plate System - 00815362021071

Buttress Plate Case
PRECISION SPINE, INC.
50-0001
In Commercial Distribution

  • 00815362021071 ()
50-0001

  • Orthopaedic surgical procedure kit, non-medicated, reusable
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