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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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Trexo Robotics - 00628719321072

Trexo Robotics XL Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321072 ()

  • XL
A001BPX

  • Programmable ambulation exoskeleton, clinical

Trexo Robotics - 00628719321065

Trexo Robotics Large Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321065 ()

  • Large
A001BPR

  • Programmable ambulation exoskeleton, clinical

Trexo Robotics - 00628719321058

Trexo Robotics Medium Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321058 ()

  • Medium
A001BPR

  • Programmable ambulation exoskeleton, clinical

Trexo Robotics - 00628719321041

Trexo Robotics Small Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321041 ()

  • Small
A001BPR

  • Programmable ambulation exoskeleton, clinical

Atalante X - 03665965000129

The Atalante X by Wandercraft is a completely self-balancing walking system for people with mobility disabilities. It is a fully powered hip-knee-ankle lower body exoskeleton with 12 actuated degrees of freedom. Atalante X is self-balancing and includes dynamic-walking control. Dynamic walking allows the Atalante X to consume significantly less power and have a more natural gait. The Atalante X is a tool for physical therapy. It is meant to be highly adjustable and be applicable for various stages of physical rehabilitation, re-mobilization and exercises.
WANDERCRAFT
ATA-002-EN US
In Commercial Distribution

  • 03665965000129 ()


  • Programmable ambulation exoskeleton, clinical

EksoNR - B168EKSONR0

EKSO BIONICS SYSTEM, Ekso NR
Ekso Bionics, Inc.
EKSONR
In Commercial Distribution

  • B168EKSONR0 ()
EKSONR

  • Programmable ambulation exoskeleton, clinical

EksoGT - B168EKSOGT0

EKSO BIONICS SYSTEM, Ekso GT
Ekso Bionics, Inc.
EKSOGT
In Commercial Distribution

  • B168EKSOGT0 ()
EKSOGT

  • Programmable ambulation exoskeleton, clinical

ExoAtlet®-II - 18800140400031

The ExoAtlet-II is intended to perform ambulatory functions in rehabilitation institutions, hospitals, or similar institutions under the supervision of a healthcare professional (HCP) such as a trained physical therapist. The ExoAtlet-II is indicated for individuals with spinal cord injuries at levels T4-L5 and individuals with spinal cord injuries at levels of C7-T3. All users must have upper extremity motor function of at least 4/5 in both arms. The ExoAtlet-II is intended for multiple users in a clinical setting (i.e., gait lab or rehabilitation center) under supervision. The ExoAtlet-II includes a battery powered exoskeleton, an ExoCrutch, and a Tablet PC. ExoAtlet-II is designed to be operated with a trained physical therapist who has received preliminary training on the Exoskeleton operation. This therapist will be familiar with the rules of the use and operational documentation. Training is conducted in a designated medical facility that is representative of the indicated environments (e.g., hospital, outpatient physical therapy clinic or similar). The training identifies safe environments of device use and uses all of the safety features found in the subject device. The training manual will be provided with the user manual along with a trainee itinerary and a trainee certification exam. The trainee needs to pass 80% of the exam questions to obtain certification.
COSMO ROBOTICS CO., Ltd.
EAS010
In Commercial Distribution

  • 18800140400031 ()


  • Programmable ambulation exoskeleton, clinical

KEEOGO - CLINICIAN KIT - 07540162060007

Powered walking assistance device
B-Temia Inc
5062601
In Commercial Distribution

  • 07540162060007 ()


  • Programmable ambulation exoskeleton, clinical

Ekso - B1431200000

The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is worn via straps on the body, legs, and feet. Battery powered motors drive knee and hip joints. It has an integrated solid torso containing the computer and power supply. It has a hand-held user interface to specify settings and initiate steps. The Ekso is used with a cane, crutch, or walker.
Ekso Bionics, Inc.
GT
In Commercial Distribution

  • B1431200000 ()


  • Programmable ambulation exoskeleton, clinical

Indego Therapy - B168501110001

Indego Therapy is a computerized, adjustable-fit powered exoskeleton, designed to restore walking function for impaired individuals.
Ekso Bionics, Inc.
501-110-001
In Commercial Distribution

  • B168501110001 ()


  • Programmable ambulation exoskeleton, clinical

Indego - B168501100000

Indego is a computerized, powered exoskeleton, designed to restore walking function for impaired individuals.
Ekso Bionics, Inc.
501-100-000
In Commercial Distribution

  • B168501100000 ()


  • Programmable ambulation exoskeleton, clinical

Origin TT Instrument Case - 09348215137854

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
592-409
In Commercial Distribution

  • 09348215137854 ()


  • Instrument tray, reusable

Super Tray inner - Origin - 09348215039905

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-36-0004
In Commercial Distribution

  • 09348215039905 ()


  • Instrument tray, reusable

Origin NS Trial Neck - 09348215087449

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5016
In Commercial Distribution

  • 09348215087449 ()


  • Surgical implant template, reusable

Origin NS Trial Neck - 09348215087418

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5013
In Commercial Distribution

  • 09348215087418 ()


  • Surgical implant template, reusable

Origin NS Stem Trial - 09348215087395

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7040
In Commercial Distribution

  • 09348215087395 ()


  • Surgical implant template, reusable

Origin NS Stem Trial - 09348215087388

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7030
In Commercial Distribution

  • 09348215087388 ()


  • Surgical implant template, reusable

Origin NS Stem Trial - 09348215087371

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7020
In Commercial Distribution

  • 09348215087371 ()


  • Surgical implant template, reusable

Origin NS Stem Trial - 09348215087364

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7010
In Commercial Distribution

  • 09348215087364 ()


  • Surgical implant template, reusable

Origin NS Stem Broach - 09348215087340

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6050
In Commercial Distribution

  • 09348215087340 ()


  • Orthopaedic broach

Origin NS Stem Broach - 09348215087326

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6030
In Commercial Distribution

  • 09348215087326 ()


  • Orthopaedic broach

Origin DAA Trial Neck - 09348215080143

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-2005
In Commercial Distribution

  • 09348215080143 ()


  • Surgical implant template, reusable

Origin DAA Trial Neck - 09348215080129

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-2003
In Commercial Distribution

  • 09348215080129 ()


  • Surgical implant template, reusable

Origin Size 18 Template - 09348215074807

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-118
In Commercial Distribution

  • 09348215074807 ()


  • Surgical implant template, reusable

Origin Size 16 Template - 09348215074791

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-116
In Commercial Distribution

  • 09348215074791 ()


  • Surgical implant template, reusable

Origin Size 12 Template - 09348215074753

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-112
In Commercial Distribution

  • 09348215074753 ()


  • Surgical implant template, reusable

Origin Size 10 Template - 09348215074739

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-110
In Commercial Distribution

  • 09348215074739 ()


  • Surgical implant template, reusable

Origin NS Trial Neck - 09348215087432

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5015
In Commercial Distribution

  • 09348215087432 ()


  • Surgical implant template, reusable

Origin NS Trial Neck - 09348215087425

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5014
In Commercial Distribution

  • 09348215087425 ()


  • Surgical implant template, reusable

Origin NS Stem Trial - 09348215087401

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7050
In Commercial Distribution

  • 09348215087401 ()


  • Surgical implant template, reusable

Origin NS Stem Trial - 09348215087357

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7000
In Commercial Distribution

  • 09348215087357 ()


  • Surgical implant template, reusable

Origin NS Stem Broach - 09348215087333

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6040
In Commercial Distribution

  • 09348215087333 ()


  • Orthopaedic broach

Origin NS Stem Broach - 09348215087319

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6020
In Commercial Distribution

  • 09348215087319 ()


  • Orthopaedic broach

Origin NS Stem Broach - 09348215087302

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6010
In Commercial Distribution

  • 09348215087302 ()


  • Orthopaedic broach

Origin NS Stem Broach - 09348215087296

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6000
In Commercial Distribution

  • 09348215087296 ()


  • Orthopaedic broach

Origin Short Trial Neck - 09348215081416

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-026
In Commercial Distribution

  • 09348215081416 ()


  • Surgical implant template, reusable

Origin DAA Trial Neck - 09348215080150

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-2006
In Commercial Distribution

  • 09348215080150 ()


  • Surgical implant template, reusable

Origin DAA Trial Neck - 09348215080136

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-2004
In Commercial Distribution

  • 09348215080136 ()


  • Surgical implant template, reusable

Origin DAA Trial Neck - 09348215080112

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-2002
In Commercial Distribution

  • 09348215080112 ()


  • Surgical implant template, reusable
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