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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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Medtronic Reusable Instruments - 00643169149649

PACKING EX0112069 25-30-36 GRAFT STATION
MEDTRONIC SOFAMOR DANEK, INC.
EX0112069
In Commercial Distribution

  • 00643169149649 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00643169181526

POSITIONER EX0512197 LARGE GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0512197
In Commercial Distribution

  • 00643169181526 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00613994922175

HOLDER EX1210102 GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX1210102
In Commercial Distribution

  • 00613994922175 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00613994922168

POSITIONER EX1110248 GRAFT GUIDE
MEDTRONIC SOFAMOR DANEK, INC.
EX1110248
In Commercial Distribution

  • 00613994922168 ()


  • Bone graft packing block

Omnia Medical PsiF - 00843511100636

PsiF Post Packer (Long Impactor) Instrument
OMNIA MEDICAL, LLC
01-01-0010
In Commercial Distribution

  • 00843511100636 ()
01-01-0010

  • Bone graft packing block

Omnia Medical VBR - 00843511100421

Omnia Medical VBR, Graft Packing Block
OMNIA MEDICAL, LLC
06-5V-PAC1
In Commercial Distribution

  • 00843511100421 ()
06-5V-PAC1

  • Bone graft packing block

Medtronic Reusable Instruments - 00613994994998

IMPACTOR X0411311 GRAFT 45 DEG
MEDTRONIC SOFAMOR DANEK, INC.
X0411311
In Commercial Distribution

  • 00613994994998 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00613994994981

IMPACTOR X0411310 GRAFT 15 DEG
MEDTRONIC SOFAMOR DANEK, INC.
X0411310
In Commercial Distribution

  • 00613994994981 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00613994994974

PUSHER X0411304 GRAFT MEDIUM
MEDTRONIC SOFAMOR DANEK, INC.
X0411304
In Commercial Distribution

  • 00613994994974 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00613994994967

PUSHER X0411303 GRAFT SMALL
MEDTRONIC SOFAMOR DANEK, INC.
X0411303
In Commercial Distribution

  • 00613994994967 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00613994992543

LOADING BLOCK EX0311274 GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0311274
In Commercial Distribution

  • 00613994992543 ()


  • Bone graft packing block

ALEUTIAN® Interbody Systems - 10888857157385

Bone Packing Mold, Two Sided,
K2M, INC.
5203-90099
In Commercial Distribution

  • 10888857157385 ()
5203-90099

  • Bone graft packing block

Medtronic Reusable Instruments - 00613994963000

TROUGH EX1110104 GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX1110104
In Commercial Distribution

  • 00613994963000 ()


  • Bone graft packing block

n/a - 00613994933423

TROUGH EX0910177 BONE GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0910177
In Commercial Distribution

  • 00613994933423 ()


  • Bone graft packing block

n/a - 00613994933409

TROUGH EX0810836 BONE GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0810836
In Commercial Distribution

  • 00613994933409 ()


  • Bone graft packing block

CASCADIA™ Interbody System - 10888857190870

Bone Packing Mold Size 10 and 12 mm, TL
K2M, INC.
6101-90002
In Commercial Distribution

  • 10888857190870 ()
6101-90002

  • Bone graft packing block

CASCADIA™ Interbody System - 10888857190856

Bone Packing Mold Size 8.5 and 10 mm, AN
K2M, INC.
6101-90000
In Commercial Distribution

  • 10888857190856 ()
6101-90000

  • Bone graft packing block

ALEUTIAN® Interbody Systems - 10888857111523

AN Lordotic - Oblique, Bone Packing Mold,
K2M, INC.
5303-90112
In Commercial Distribution

  • 10888857111523 ()
5303-90112

  • Bone graft packing block

SANTORINI™ Corpectomy Cage System - 10888857023581

Bone Packing Mold Base
K2M, INC.
1708-90043
In Commercial Distribution

  • 10888857023581 ()
1708-90043

  • Bone graft packing block

SANTORINI™ Corpectomy Cage System - 10888857023529

Bone Packing Mold, Size 12x17 mm
K2M, INC.
1708-90033
In Commercial Distribution

  • 10888857023529 ()
1708-90033

  • Bone graft packing block

SANTORINI™ Corpectomy Cage System - 10888857023512

Bone Packing Mold, Size 12x14 mm
K2M, INC.
1708-90032
In Commercial Distribution

  • 10888857023512 ()
1708-90032

  • Bone graft packing block

Surgical Instrument - 08806390885331

No Description
Jeil Medical Corporation
111-299
In Commercial Distribution

  • 08806390885331 ()


  • Bone graft packing block

INNESIS PEEK CERVICAL CAGE - 08809763504761

Graft Case
BK MEDITECH CO.,LTD.
42645
In Commercial Distribution

  • 08809763504761 ()


  • Bone graft packing block

INNESIS PEEK TL CAGE - 08809763504495

Bone Filler
BK MEDITECH CO.,LTD.
52865
In Commercial Distribution

  • 08809763504495 ()


  • Bone graft packing block

INNESIS PEEK CERVICAL CAGE - 08809763504426

Graft Case
BK MEDITECH CO.,LTD.
42640
In Commercial Distribution

  • 08809763504426 ()


  • Bone graft packing block

INNESIS PEEK CAGE - 08809763504204

Cage Support
BK MEDITECH CO.,LTD.
52750-10
In Commercial Distribution

  • 08809763504204 ()


  • Bone graft packing block

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

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

KEEOGO - CLINICIAN KIT - 07540162060007

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

  • 07540162060007 ()


  • Programmable ambulation exoskeleton, clinical

ReWalk(TM) Rehabilitaiton - 00861803000327

Powered Exoskeleton - rehabilitation institution use
REWALK ROBOTICS LTD
50-30-0001
In Commercial Distribution

  • 00861803000327 ()


  • Programmable ambulation exoskeleton, clinical

ReStore - 00860001744507

The device is a lightweight, wearable, battery-powered soft orthotic exosuit intended to be used to preform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia / hemiparesis due to stroke.
REWALK ROBOTICS LTD
50-40-0001
In Commercial Distribution

  • 00860001744507 ()


  • Programmable ambulation exoskeleton, clinical

Indego Therapy - M704501110001

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

  • M704501110001 ()


  • Programmable ambulation exoskeleton, clinical

Indego - M704501100000

Indego is a computerized, powered exoskeleton, designed to restore walking function for impaired individuals.
EKSO BIONICS, INC.
501-100-000
In Commercial Distribution

  • M704501100000 ()


  • Programmable ambulation exoskeleton, clinical

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

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 - 09348215087425

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

  • 09348215087425 ()


  • 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 - 09348215087401

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

  • 09348215087401 ()


  • 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 Trial Neck - 09348215087432

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

  • 09348215087432 ()


  • 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 - 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 Short Trial Neck - 09348215081416

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

  • 09348215081416 ()


  • Surgical implant template, reusable
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