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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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Apelo® / Apelo® MIS - M68120108400000

MIS Torque Driver
ATLAS SPINE, INC.
2010-84-0000
In Commercial Distribution

  • M68120108400000 ()
2010-84-0000

  • Surgical instrument handle, torque-limiting

Apelo® / Apelo® MIS - M68120108200000

Expansion Locking Collar Starter
ATLAS SPINE, INC.
2010-82-0000
In Commercial Distribution

  • M68120108200000 ()
2010-82-0000

  • Surgical screwdriver, reusable

Apelo® / Apelo® MIS - M68120106900000

Guidewire Lock
ATLAS SPINE, INC.
2010-69-0000
In Commercial Distribution

  • M68120106900000 ()
2010-69-0000

  • Manual wire driver

Apelo® / Apelo® MIS - M68120106800000

MIS Retention Shaft
ATLAS SPINE, INC.
2010-68-0000
In Commercial Distribution

  • M68120106800000 ()
2010-68-0000

  • Surgical screwdriver, reusable

Apelo® / Apelo® MIS - M68120106700000

MIS Cannulated Screwdriver
ATLAS SPINE, INC.
2010-67-0000
In Commercial Distribution

  • M68120106700000 ()
2010-67-0000

  • Surgical screwdriver, reusable

Apelo® / Apelo® MIS - M68120106000000

Cannulated Poly Driver
ATLAS SPINE, INC.
2010-60-0000
In Commercial Distribution

  • M68120106000000 ()
2010-60-0000

  • Surgical screwdriver, reusable

Apelo® / Apelo® MIS - M68120067300000

Dual Locking Collar Starter
ATLAS SPINE, INC.
2006-73-0000
In Commercial Distribution

  • M68120067300000 ()
2006-73-0000

  • Surgical screwdriver, reusable

Apelo® / Apelo® MIS - M68120067200000

Cannulated Reduction Poly Driver
ATLAS SPINE, INC.
2006-72-0000
In Commercial Distribution

  • M68120067200000 ()
2006-72-0000

  • Surgical screwdriver, reusable

Apelo® / Apelo® MIS - M68120066700000

Cannulated Screwdriver
ATLAS SPINE, INC.
2006-67-0000
In Commercial Distribution

  • M68120066700000 ()
2006-67-0000

  • Surgical screwdriver, reusable

Apelo® / Apelo® MIS - M68120066600000

Modular Cam Driver
ATLAS SPINE, INC.
2006-66-0000
In Commercial Distribution

  • M68120066600000 ()
2006-66-0000

  • Surgical screwdriver, reusable
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