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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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DENALI Spinal System - 10888857010628

Torque Limiting Handle Size 90 in-lb (10.2 N-m)
K2M, INC.
101-90219
In Commercial Distribution

  • 10888857010628 ()
101-90219

  • Surgical instrument handle, torque-limiting

DENALI Spinal System - 10888857010611

In Situ Bender, Narrow (Right)
K2M, INC.
101-90218
In Commercial Distribution

  • 10888857010611 ()
101-90218

  • Manual orthopaedic bender, reusable

DENALI Spinal System - 10888857010604

In Situ Bender, Narrow (Left)
K2M, INC.
101-90217
In Commercial Distribution

  • 10888857010604 ()
101-90217

  • Manual orthopaedic bender, reusable

DENALI Spinal System - 10888857010574

NB LP Handle
K2M, INC.
101-90213
In Commercial Distribution

  • 10888857010574 ()
101-90213

  • Surgical instrument handle, torque-limiting

DENALI Spinal System - 10888857010529

Torque Limiting Shaft (Short) Size 25
K2M, INC.
101-90208
In Commercial Distribution

  • 10888857010529 ()
101-90208

  • Surgical screwdriver, reusable

DENALI Spinal System - 10888857010444

Torque Indicating Wrench
K2M, INC.
101-90190
In Commercial Distribution

  • 10888857010444 ()
101-90190

  • Orthopaedic implant/instrument assembling device

DENALI Spinal System - 10888857010314

Anti Torque Alignment Tube (Short)
K2M, INC.
101-90148
In Commercial Distribution

  • 10888857010314 ()
101-90148

  • Orthopaedic fixation implant alignment tool

DENALI Spinal System - 10888857010260

Rod Template Size 400 mm
K2M, INC.
101-90143
In Commercial Distribution

  • 10888857010260 ()
101-90143

  • Surgical implant template, single-use

DENALI Spinal System - 10888857010253

Rod Template Size 300 mm
K2M, INC.
101-90142
In Commercial Distribution

  • 10888857010253 ()
101-90142

  • Surgical implant template, single-use

DENALI Spinal System - 10888857010239

Saddle Hook Holder
K2M, INC.
101-90138
In Commercial Distribution

  • 10888857010239 ()
101-90138

  • Surgical implant/trial-implant/sizer holder, reusable
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