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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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primaLOK SP - 00813210021785

primaLOK SP 28mm Medium Boxless Implant, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0828-00
In Commercial Distribution

  • 00813210021785 ()

  • Width: 28 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

OsteoMed - 00845694026734

PrimaLOK SP 18mm Implant Assembly
OSTEOMED LLC
800-0118
Not in Commercial Distribution

  • 00845694026734 ()

  • Height: 18 Millimeter
800-0118

  • Orthopaedic fixation plate kit, non-bioabsorbable, non-sterile

GUIDED GROWTH PLATE SYSTEM - 18054242518112

STERILIZATION BOX COMPLETE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18054242518112 ()
180990C

  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

Miot Plating System - 18032937160228

MIOT PLATE WIRE 45 MM KIT
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032937160228 ()

  • THREAD LENGTH 45 MM
SP37245

  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

Miot Plating System - 18032937160211

MIOT PLATE WIRE 40 MM KIT
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032937160211 ()

  • THREAD LENGTH 40 MM
SP37240

  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

Miot Plating System - 18032937160204

MIOT PLATE WIRE 35 MM KIT
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032937160204 ()

  • THREAD LENGTH 35 MM
SP37235

  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

Miot Plating System - 18032937160198

MIOT PLATE WIRE 30 MM KIT
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032937160198 ()

  • THREAD LENGTH 30 MM
SP37230

  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

Miot Plating System - 18032937160181

MIOT PLATE WIRE 25 MM KIT
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032937160181 ()

  • THREAD LENGTH 25 MM
SP37225

  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

Miot Plating System - 18032937160174

MIOT PLATE WIRE 23 MM KIT
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032937160174 ()

  • THREAD LENGTH 23 MM
SP37223

  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

Miot Plating System - 18032937160167

MIOT PLATE WIRE 21 MM KIT
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032937160167 ()

  • THREAD LENGTH 21 MM
SP37221

  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
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