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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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4CIS® INSTRUMENT SYSTEM - 08806373578694

Initial Driver
ALPHANOX CO.,LTD.
9807-0036
In Commercial Distribution

  • 08806373578694 ()
9807-0036

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373577185

SCREW DRIVER
ALPHANOX CO.,LTD.
9807-0024
In Commercial Distribution

  • 08806373577185 ()
9807-0024

  • External spinal fixation system

NeuroPro® - 00898142001296

Driver Handle
Kinamed, Inc.
14-1T1-0100
In Commercial Distribution

  • 00898142001296 ()
14-1T1-0100

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform TI Pedicle Screw System - 00840019929172

Polyaxial Driver
PRECISION SPINE, INC.
39-SP-0720
In Commercial Distribution

  • 00840019929172 ()
39-SP-0720

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform Pedicle Screw System - 00840019928731

Polyaxial Driver
PRECISION SPINE, INC.
39-SP-0700
In Commercial Distribution

  • 00840019928731 ()
39-SP-0700

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform POCT System - 00840019926423

Adjustment Driver
PRECISION SPINE, INC.
55-IN-0060
In Commercial Distribution

  • 00840019926423 ()
55-IN-0060

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Reform POCT System - 00840019926409

Polyaxial Driver
PRECISION SPINE, INC.
55-IN-0050
In Commercial Distribution

  • 00840019926409 ()
55-IN-0050

  • Orthopaedic surgical procedure kit, non-medicated, reusable

SureLOK MIS 3L - 00840019920148

Reduction Driver
PRECISION SPINE, INC.
63-RD-0321
In Commercial Distribution

  • 00840019920148 ()
63-RD-0321

  • Orthopaedic surgical procedure kit, non-medicated, reusable

MD Vue Lateral Access - 00840019919500

Hex Driver
PRECISION SPINE, INC.
54-HD-0100
In Commercial Distribution

  • 00840019919500 ()
54-HD-0100

  • Neurosurgical retraction system, spinal

Invictus - 00190376185811

Final Driver
ALPHATEC SPINE, INC.
17138
In Commercial Distribution

  • 00190376185811 ()


  • Surgical screwdriver, reusable
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