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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
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