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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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Proficient™ Posterior Cervical Spine System - 10840642115260

Cannulated, Screw, 5.0 mm x 24 mm
Spine Wave, Inc.
11-8465
In Commercial Distribution

  • 10840642115260 ()
11-8465

  • Spinal bone screw, non-bioabsorbable

Proficient™ Posterior Cervical Spine System - 10840642113556

Cannulated, Screw, 3.8 mm x 24 mm
Spine Wave, Inc.
11-8258
In Commercial Distribution

  • 10840642113556 ()
11-8258

  • Spinal bone screw, non-bioabsorbable

OVERWATCH - 00840606159364

K-WIRE CADDY, END CAP 24" TROCAR NI
SPINAL ELEMENTS, INC.
108-328-038
In Commercial Distribution

  • 00840606159364 ()


  • Device sterilization/disinfection container, reusable

OVERWATCH - 00840606159357

K-WIRE CADDY, END CAP 24" BLUNT NI
SPINAL ELEMENTS, INC.
108-328-037
In Commercial Distribution

  • 00840606159357 ()


  • Device sterilization/disinfection container, reusable

OVERWATCH - 00840606159166

K-WIRE CADDY, END CAP 24" TROCAR SS
SPINAL ELEMENTS, INC.
108-328-018
In Commercial Distribution

  • 00840606159166 ()


  • Device sterilization/disinfection container, reusable

OVERWATCH - 00840606159159

K-WIRE CADDY, END CAP 24" BLUNT SS
SPINAL ELEMENTS, INC.
108-328-017
In Commercial Distribution

  • 00840606159159 ()


  • Device sterilization/disinfection container, reusable

Proficient® Posterior Cervical Spine System - 10840642129175

Extended-Tab Smooth-Shank Screw, 4.2 mm × 24 mm
Spine Wave, Inc.
11-9540
In Commercial Distribution

  • 10840642129175 ()
11-9540

  • Spinal bone screw, non-bioabsorbable

Proficient® Posterior Cervical Spine System - 10840642128819

Extended-Tab Smooth-Shank Screw, 3.8 mm × 24 mm
Spine Wave, Inc.
11-9504
In Commercial Distribution

  • 10840642128819 ()
11-9504

  • Spinal bone screw, non-bioabsorbable

Proficient® Posterior Cervical Spine System - 10840642128369

Cannulated Smooth-Shank Screw, 4.2 mm × 24 mm
Spine Wave, Inc.
11-9468
In Commercial Distribution

  • 10840642128369 ()
11-9468

  • Spinal bone screw, non-bioabsorbable

Proficient® Posterior Cervical Spine System - 10840642128093

Cannulated Smooth-Shank Screw, 3.8 mm × 24 mm
Spine Wave, Inc.
11-9558
In Commercial Distribution

  • 10840642128093 ()
11-9558

  • Spinal bone screw, non-bioabsorbable
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