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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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Sierra™ - 10889981042523

Sierra Screw, 03.5 x 38mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
Seaspine Orthopedics Corporation
50-3538
Not in Commercial Distribution

  • 10889981042523 ()

  • 3.5 Dia X 38mm
50-3538

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042516

Sierra Screw, 03.5 x 36mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
Seaspine Orthopedics Corporation
50-3536
Not in Commercial Distribution

  • 10889981042516 ()

  • 3.5 Dia X 36mm
50-3536

  • Cannulated surgical drill bit, single-use

NewPort - 10889981086480

NewPort Cap Remover
Seaspine Orthopedics Corporation
91-8668
In Commercial Distribution

  • 10889981086480 ()
91-8668

  • Orthopaedic implant driver

NewPort - 10889981086473

Extended Bullet Nose Saddle Driver Shaft
Seaspine Orthopedics Corporation
91-8667
In Commercial Distribution

  • 10889981086473 ()
91-8667

  • Orthopaedic implant driver

NewPort - 10889981086466

Bullet Nose Saddle Driver Shaft
Seaspine Orthopedics Corporation
91-8666
In Commercial Distribution

  • 10889981086466 ()
91-8666

  • Orthopaedic implant driver

NewPort - 10889981086459

Driver Over-Sleeve, Plastic
Seaspine Orthopedics Corporation
91-8665
In Commercial Distribution

  • 10889981086459 ()
91-8665

  • Orthopaedic implantation sleeve, reusable

NewPort - 10889981086442

Driver Over-Sleeve, SS
Seaspine Orthopedics Corporation
91-8664
In Commercial Distribution

  • 10889981086442 ()
91-8664

  • Orthopaedic implantation sleeve, reusable

NewPort - 10889981086435

Bullet Nose Qwik Driver Sleeve
Seaspine Orthopedics Corporation
91-8663
In Commercial Distribution

  • 10889981086435 ()
91-8663

  • Orthopaedic implantation sleeve, reusable

NewPort - 10889981086428

Cannulated 3mm Pedicle Driver
Seaspine Orthopedics Corporation
91-8662
In Commercial Distribution

  • 10889981086428 ()

  • 3mm
91-8662

  • Surgical screwdriver, reusable

NewPort - 10889981086411

Qwik Driver Shaft
Seaspine Orthopedics Corporation
91-8661
In Commercial Distribution

  • 10889981086411 ()
91-8661

  • Orthopaedic implant driver

NewPort - 10889981086398

Ozat Hex Driver Shaft
Seaspine Orthopedics Corporation
91-8659
In Commercial Distribution

  • 10889981086398 ()
91-8659

  • Orthopaedic implant driver

NewPort - 10889981086381

Hex Saddle Driver Shaft
Seaspine Orthopedics Corporation
91-8658
In Commercial Distribution

  • 10889981086381 ()
91-8658

  • Orthopaedic implant driver

NewPort - 10889981085254

NewPort Express Driver Shaft
Seaspine Orthopedics Corporation
91-8440
In Commercial Distribution

  • 10889981085254 ()
91-8440

  • Orthopaedic implant driver

NewPort - 10889981085247

NewPort Express Driver Sleeve
Seaspine Orthopedics Corporation
91-8439
In Commercial Distribution

  • 10889981085247 ()
91-8439

  • Orthopaedic implantation sleeve, reusable

NewPort - 10889981085179

Hex Driver, 4mm
Seaspine Orthopedics Corporation
91-8432
In Commercial Distribution

  • 10889981085179 ()

  • 4mm
91-8432

  • Surgical screwdriver, reusable

NewPort - 10889981084127

2.5mm Driver, Modular
Seaspine Orthopedics Corporation
91-8325
In Commercial Distribution

  • 10889981084127 ()

  • 2.5mm
91-8325

  • Surgical screwdriver, reusable

NewPort - 10889981083847

Screw Inserter Hex Shaft
Seaspine Orthopedics Corporation
91-8294
In Commercial Distribution

  • 10889981083847 ()
91-8294

  • Orthopaedic implant driver

NewPort - 10889981083700

COMPRESSOR
Seaspine Orthopedics Corporation
91-8272
In Commercial Distribution

  • 10889981083700 ()
91-8272

  • Orthopaedic implant driver

NewPort - 10889981083694

Loader Assembly
Seaspine Orthopedics Corporation
91-8271
In Commercial Distribution

  • 10889981083694 ()
91-8271

  • Orthopaedic implant driver

NewPort - 10889981083632

Dial Lock Cap Loader/Retriever
Seaspine Orthopedics Corporation
91-8259
In Commercial Distribution

  • 10889981083632 ()
91-8259

  • Orthopaedic implant driver

NewPort - 10889981083618

Newport Rod and Cap Confirmation Tool
Seaspine Orthopedics Corporation
91-8256
In Commercial Distribution

  • 10889981083618 ()
91-8256

  • Orthopaedic implant driver

NewPort - 10889981083496

Cannulated Drill for Ø 7.5 Screw
Seaspine Orthopedics Corporation
91-8244
In Commercial Distribution

  • 10889981083496 ()

  • 7.5 Deg
91-8244

  • Orthopaedic implant driver

NewPort - 10889981083489

Cannulated Drill for Ø 7.0 Screw
Seaspine Orthopedics Corporation
91-8243
In Commercial Distribution

  • 10889981083489 ()

  • 7.0 Deg
91-8243

  • Orthopaedic implant driver

NewPort - 10889981083472

Cannulated Drill for DIA 6.5 Screw
Seaspine Orthopedics Corporation
91-8242
In Commercial Distribution

  • 10889981083472 ()

  • 6.5 Deg
91-8242

  • Orthopaedic implant driver

NewPort - 10889981083465

Cannulated Drill for Ø 6.0 Screw
Seaspine Orthopedics Corporation
91-8241
In Commercial Distribution

  • 10889981083465 ()

  • 6.0 Deg
91-8241

  • Orthopaedic implant driver

NewPort - 10889981083458

Cannulated Drill for Ø 5.5 Screw
Seaspine Orthopedics Corporation
91-8240
In Commercial Distribution

  • 10889981083458 ()

  • 5.5 Deg
91-8240

  • Orthopaedic implant driver

NewPort - 10889981083366

Screw Driver Sleeve
Seaspine Orthopedics Corporation
91-8231
In Commercial Distribution

  • 10889981083366 ()
91-8231

  • Orthopaedic implantation sleeve, reusable

NewPort - 10889981083359

Screw Driver Shaft
Seaspine Orthopedics Corporation
91-8230
In Commercial Distribution

  • 10889981083359 ()
91-8230

  • Orthopaedic implant driver

NewPort - 10889981083298

Tab Remover
Seaspine Orthopedics Corporation
91-8223
In Commercial Distribution

  • 10889981083298 ()
91-8223

  • Orthopaedic implant driver

NewPort - 10889981083250

Rod Confirmation Tool
Seaspine Orthopedics Corporation
91-8219
In Commercial Distribution

  • 10889981083250 ()
91-8219

  • Orthopaedic implant driver

NewPort - 10889981083168

Screw Driver
Seaspine Orthopedics Corporation
91-8210
In Commercial Distribution

  • 10889981083168 ()
91-8210

  • Surgical screwdriver, reusable

Malibu™ - 10889981083014

Locking Cannulated DLTA AO Driver, Short
Seaspine Orthopedics Corporation
91-7253
In Commercial Distribution

  • 10889981083014 ()
91-7253

  • Orthopaedic implant driver

Malibu - 10889981082925

Locking Malibu Driver Free Sleeve
Seaspine Orthopedics Corporation
91-7244
In Commercial Distribution

  • 10889981082925 ()
91-7244

  • Orthopaedic implantation sleeve, reusable

Malibu - 10889981082901

Locking Malibu Driver Sleeve
Seaspine Orthopedics Corporation
91-7242
In Commercial Distribution

  • 10889981082901 ()
91-7242

  • Orthopaedic implantation sleeve, reusable

Malibu - 10889981082895

Locking Malibu Driver Shaft
Seaspine Orthopedics Corporation
91-7241
In Commercial Distribution

  • 10889981082895 ()
91-7241

  • Orthopaedic implant driver

Malibu - 10889981082710

DLTA Screw Driver Shaft, Short
Seaspine Orthopedics Corporation
91-7116
In Commercial Distribution

  • 10889981082710 ()
91-7116

  • Surgical screwdriver, reusable

Malibu - 10889981082703

DLTA Screw Driver Shaft
Seaspine Orthopedics Corporation
91-7115
In Commercial Distribution

  • 10889981082703 ()
91-7115

  • Surgical screwdriver, reusable

Malibu - 10889981082260

Monoaxial Screw Driver Shaft
Seaspine Orthopedics Corporation
91-6111
In Commercial Distribution

  • 10889981082260 ()
91-6111

  • Surgical screwdriver, reusable

Malibu - 10889981082253

Monoaxial Screw Driver Shaft, 1/4"
Seaspine Orthopedics Corporation
91-6110
In Commercial Distribution

  • 10889981082253 ()

  • 1/4"
91-6110

  • Orthopaedic implant driver

Malibu - 10889981082246

Monoaxial Screw Driver
Seaspine Orthopedics Corporation
91-6109
In Commercial Distribution

  • 10889981082246 ()
91-6109

  • Surgical screwdriver, reusable

Malibu - 10889981082086

Malibu/TSC Screw Driver Shaft
Seaspine Orthopedics Corporation
91-3111
In Commercial Distribution

  • 10889981082086 ()
91-3111

  • Orthopaedic implant driver

Malibu - 10889981081676

Torque Indicating Driver
Seaspine Orthopedics Corporation
91-2515
In Commercial Distribution

  • 10889981081676 ()
91-2515

  • Orthopaedic implant driver

Malibu - 10889981081669

Torque Limiting Driver
Seaspine Orthopedics Corporation
91-2514
In Commercial Distribution

  • 10889981081669 ()
91-2514

  • Orthopaedic implant driver

Malibu - 10889981081652

Adjustable Torque Limiting Driver
Seaspine Orthopedics Corporation
91-2513
In Commercial Distribution

  • 10889981081652 ()
91-2513

  • Orthopaedic implant driver

Malibu - 10889981080938

Self-Retaining Driver Sleeve
Seaspine Orthopedics Corporation
91-2166
In Commercial Distribution

  • 10889981080938 ()
91-2166

  • Orthopaedic implantation sleeve, reusable

Malibu - 10889981080921

Polyaxial Self-Retaining Driver
Seaspine Orthopedics Corporation
91-2165
In Commercial Distribution

  • 10889981080921 ()
91-2165

  • Orthopaedic implant driver

Malibu - 10889981080914

Screw Driver Medium, 4mm
Seaspine Orthopedics Corporation
91-2164
In Commercial Distribution

  • 10889981080914 ()

  • 4mm
91-2164

  • Surgical screwdriver, reusable

Malibu - 10889981080907

Screw Driver Medium, 3mm
Seaspine Orthopedics Corporation
91-2163
In Commercial Distribution

  • 10889981080907 ()

  • 3mm
91-2163

  • Surgical screwdriver, reusable

Malibu - 10889981080891

Screw Driver, Short 3mm
Seaspine Orthopedics Corporation
91-2153
In Commercial Distribution

  • 10889981080891 ()

  • 3mm
91-2153

  • Surgical screwdriver, reusable

Malibu - 10889981080761

Modular Poly Driver Sleeve, Locking
Seaspine Orthopedics Corporation
91-2135
In Commercial Distribution

  • 10889981080761 ()
91-2135

  • Orthopaedic implantation sleeve, reusable
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