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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 Type Device Class Implantable

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Stainless Steel - 10381780018964

Locking Screw
Seaspine, Inc.
25-17-7555
Not in Commercial Distribution

  • M248251775551 ()
  • 10381780018964 ()
25-17-7555

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780018902

Cannulated Polyaxial Screw, 7.5mm x 45mm
Seaspine, Inc.
18-7545
Not in Commercial Distribution

  • M5561875451 ()
  • 10381780018902 ()

  • 7.5mm x 45mm
18-7545

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780018896

Cannulated Polyaxial Screw, 7.5mm x 40mm
Seaspine, Inc.
18-7540
Not in Commercial Distribution

  • M5561875401 ()
  • 10381780018896 ()

  • 7.5mm x 40mm
18-7540

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780018889

Cannulated Polyaxial Screw, 6.5 x 50mm
Seaspine, Inc.
18-6550
Not in Commercial Distribution

  • M5561865501 ()
  • 10381780018889 ()

  • 6.5 x 50mm
18-6550

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780018872

Cannulated Polyaxial Screw, 6.5mm x 45mm
Seaspine, Inc.
18-6545
Not in Commercial Distribution

  • M5561865451 ()
  • 10381780018872 ()

  • 6.5mm x 45mm
18-6545

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780018865

Cannulated Polyaxial Screw, 6.5mm x 40mm
Seaspine, Inc.
18-6540
Not in Commercial Distribution

  • M5561865401 ()
  • 10381780018865 ()

  • 6.5mm x 40mm
18-6540

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780018858

Cannulated Polyaxial Screw, 6.5mm x 35mm
Seaspine, Inc.
18-6535
Not in Commercial Distribution

  • M5561865351 ()
  • 10381780018858 ()

  • 6.5mm x 35mm
18-6535

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780018841

Cannulated Polyaxial Screw, 5.5mm x 45mm
Seaspine, Inc.
18-5545
Not in Commercial Distribution

  • M5561855451 ()
  • 10381780018841 ()

  • 5.5mm x 45mm
18-5545

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780018834

Cannulated Polyaxial Screw, 5.5 x 40mm
Seaspine, Inc.
18-5540
Not in Commercial Distribution

  • M5561855401 ()
  • 10381780018834 ()

  • 5.5 x 40mm
18-5540

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013389

Monoaxial Screw, 9.5 x 55mm
Seaspine, Inc.
16-9555
Not in Commercial Distribution

  • M5561695551 ()
  • 10381780013389 ()

  • 9.5 x 55mm
16-9555

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013372

Monoaxial Screw, 9.5 x 50mm
Seaspine, Inc.
16-9550
Not in Commercial Distribution

  • M5561695501 ()
  • 10381780013372 ()

  • 9.5 x 50mm
16-9550

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013365

Monoaxial Screw, 9.5 x 45mm
Seaspine, Inc.
16-9545
Not in Commercial Distribution

  • M5561695451 ()
  • 10381780013365 ()

  • 9.5 x 45mm
16-9545

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013358

Monoaxial Screw, 9.5 x 40mm
Seaspine, Inc.
16-9540
Not in Commercial Distribution

  • M5561695401 ()
  • 10381780013358 ()

  • 9.5 x 40mm
16-9540

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013341

Monoaxial Screw, 9.5 x 35mm
Seaspine, Inc.
16-9535
Not in Commercial Distribution

  • M5561695351 ()
  • 10381780013341 ()

  • 9.5 x 35mm
16-9535

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013334

Monoaxial Screw, 8.5 x 55mm
Seaspine, Inc.
16-8555
Not in Commercial Distribution

  • M5561685551 ()
  • 10381780013334 ()

  • 8.5 x 55mm
16-8555

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013327

Monoaxial Screw, 8.5 x 50mm
Seaspine, Inc.
16-8550
Not in Commercial Distribution

  • M5561685501 ()
  • 10381780013327 ()

  • 8.5 x 50mm
16-8550

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013310

Monoaxial Screw, 8.5 x 45mm
Seaspine, Inc.
16-8545
Not in Commercial Distribution

  • M5561685451 ()
  • 10381780013310 ()

  • 8.5 x 45mm
16-8545

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013303

Monoaxial Screw, 8.5 x 40mm
Seaspine, Inc.
16-8540
Not in Commercial Distribution

  • M5561685401 ()
  • 10381780013303 ()

  • 8.5 x 40mm
16-8540

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013297

Monoaxial Screw, 8.5 x 35mm
Seaspine, Inc.
16-8535
Not in Commercial Distribution

  • M5561685351 ()
  • 10381780013297 ()

  • 8.5 x 35mm
16-8535

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013280

Monoaxial Screw, 7.5 x 55mm
Seaspine, Inc.
16-7555
Not in Commercial Distribution

  • M5561675551 ()
  • 10381780013280 ()

  • 7.5 x 55mm
16-7555

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013273

Monoaxial Screw, 7.5 x 50mm
Seaspine, Inc.
16-7550
Not in Commercial Distribution

  • M5561675501 ()
  • 10381780013273 ()

  • 7.5 x 50mm
16-7550

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013266

Monoaxial Screw, 7.5 x 45mm
Seaspine, Inc.
16-7545
Not in Commercial Distribution

  • M5561675451 ()
  • 10381780013266 ()

  • 7.5 x 45mm
16-7545

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013259

Monoaxial Screw, 7.5 x 40mm
Seaspine, Inc.
16-7540
Not in Commercial Distribution

  • M5561675401 ()
  • 10381780013259 ()

  • 7.5 x 40mm
16-7540

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013242

Monoaxial Screw, 7.5 x 35mm
Seaspine, Inc.
16-7535
Not in Commercial Distribution

  • M5561675351 ()
  • 10381780013242 ()

  • 7.5 x 35mm
16-7535

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013235

Monoaxial Screw, 6.5 x 55mm
Seaspine, Inc.
16-6555
Not in Commercial Distribution

  • M5561665551 ()
  • 10381780013235 ()

  • 6.5 x 55mm
16-6555

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013228

Monoaxial Screw, 6.5 x 50mm
Seaspine, Inc.
16-6550
Not in Commercial Distribution

  • M5561665501 ()
  • 10381780013228 ()

  • 6.5 x 50mm
16-6550

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013211

Monoaxial Screw, 6.5 x 45mm
Seaspine, Inc.
16-6545
Not in Commercial Distribution

  • M5561665451 ()
  • 10381780013211 ()

  • 6.5 x 45mm
16-6545

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013204

Monoaxial Screw, 6.5 x 40mm
Seaspine, Inc.
16-6540
Not in Commercial Distribution

  • M5561665401 ()
  • 10381780013204 ()

  • 6.5 x 40mm
16-6540

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013198

Monoaxial Screw, 6.5 x 35mm
Seaspine, Inc.
16-6535
Not in Commercial Distribution

  • M5561665351 ()
  • 10381780013198 ()

  • 6.5 x 35mm
16-6535

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013181

Monoaxial Screw, 5.5 x 50mm
Seaspine, Inc.
16-5550
Not in Commercial Distribution

  • M5561655501 ()
  • 10381780013181 ()

  • 5.5 x 50mm
16-5550

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013174

Monoaxial Screw, 5.5 x 45mm
Seaspine, Inc.
16-5545
Not in Commercial Distribution

  • M5561655451 ()
  • 10381780013174 ()

  • 5.5 x 45mm
16-5545

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013167

Monoaxial Screw, 5.5 x 40mm
Seaspine, Inc.
16-5540
Not in Commercial Distribution

  • M5561655401 ()
  • 10381780013167 ()

  • 5.5 x 40mm
16-5540

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013150

Monoaxial Screw, 5.5 x 35mm
Seaspine, Inc.
16-5535
Not in Commercial Distribution

  • M5561655351 ()
  • 10381780013150 ()

  • 5.5 x 35mm
16-5535

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013143

Monoaxial Screw, 5.5 x 30mm
Seaspine, Inc.
16-5530
Not in Commercial Distribution

  • M5561655301 ()
  • 10381780013143 ()

  • 5.5 x 30mm
16-5530

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013136

Monoaxial Screw, 4.5 x 40mm
Seaspine, Inc.
16-4540
Not in Commercial Distribution

  • M5561645401 ()
  • 10381780013136 ()

  • 4.5 x 40mm
16-4540

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013129

Malibu Set Screw
Seaspine, Inc.
16-0015
Not in Commercial Distribution

  • M5561600151 ()
  • 10381780013129 ()
16-0015

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013105

MONOAXIAL LOCKING CAP
Seaspine, Inc.
16-0010
Not in Commercial Distribution

  • M5561600101 ()
  • 10381780013105 ()
16-0010

  • Bone-screw internal spinal fixation system, non-sterile

UCR - 10381780013099

Cap, LP
Seaspine, Inc.
14-0020
Not in Commercial Distribution

  • M5561400201 ()
  • 10381780013099 ()

  • LP
14-0020

  • Bone-screw internal spinal fixation system, non-sterile

UCR - 10381780013082

SetScrew, LP
Seaspine, Inc.
14-0010
Not in Commercial Distribution

  • M5561400101 ()
  • 10381780013082 ()

  • LP
14-0010

  • Bone-screw internal spinal fixation system, non-sterile

Malibu - 10381780013075

Malibu Polyaxial Reduction Screw,7.5 x 55mm
Seaspine, Inc.
13-7555
Not in Commercial Distribution

  • M5561375551 ()
  • 10381780013075 ()

  • 7.5 x 55mm
13-7555

  • Bone-screw internal spinal fixation system, non-sterile
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