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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™ - 10889981042646

Sierra Screw, 04.0 x 28mm. 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
50-4028
In Commercial Distribution

  • 10889981042646 ()

  • 4.0 Dia X 28mm
50-4028

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042639

Sierra Screw, 04.0 x 26mm. 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
50-4026
In Commercial Distribution

  • 10889981042639 ()

  • 4.0 Dia X 26mm
50-4026

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042615

Sierra Screw, 04.0 x 22mm. 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
50-4022
In Commercial Distribution

  • 10889981042615 ()

  • 4.0 Dia X 22mm
50-4022

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042608

Sierra Screw, 04.0 x 20mm. 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
50-4020
In Commercial Distribution

  • 10889981042608 ()

  • 4.0 Dia X 20mm
50-4020

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042585

Sierra Screw, 04.0 x 16mm. 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
50-4016
In Commercial Distribution

  • 10889981042585 ()

  • 4.0 Dia X 16mm
50-4016

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042561

Sierra Screw, 04.0 x 12mm. 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
50-4012
In Commercial Distribution

  • 10889981042561 ()

  • 4.0 Dia X 12mm
50-4012

  • Cannulated surgical drill bit, single-use

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™ - 10889981042493

Sierra Screw, 03.5 x 32mm. 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
50-3532
In Commercial Distribution

  • 10889981042493 ()

  • 3.5 Dia X 32mm
50-3532

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042356

Contoured Crossbar, Large, 3.5 Rod. 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
50-2013
In Commercial Distribution

  • 10889981042356 ()

  • 3.5
50-2013

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042349

Contoured Crossbar, Medium, 3.5 Rod. 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
50-2012
In Commercial Distribution

  • 10889981042349 ()

  • 3.5
50-2012

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042325

Sierra Locking Cap. 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
50-1000
In Commercial Distribution

  • 10889981042325 ()
50-1000

  • Cannulated surgical drill bit, single-use

PLIF Allograft - 10889981087753

Slotted Mallet
Seaspine Orthopedics Corporation
93-0151
In Commercial Distribution

  • 10889981087753 ()
93-0151

  • Surgical mallet

Zuma-C - 10889981087401

Cervical Screw Driver
Seaspine Orthopedics Corporation
92-5121
In Commercial Distribution

  • 10889981087401 ()
92-5121

  • Orthopaedic implant driver

Sonoma - 10889981087319

Split Tip Driver
Seaspine Orthopedics Corporation
92-0200
In Commercial Distribution

  • 10889981087319 ()
92-0200

  • Orthopaedic implant driver

Sonoma - 10889981087289

Mini Drill 16mm
Seaspine Orthopedics Corporation
92-0196
In Commercial Distribution

  • 10889981087289 ()

  • 16mm
92-0196

  • Orthopaedic implant driver

Sonoma - 10889981087272

Mini Drill 14mm
Seaspine Orthopedics Corporation
92-0194
In Commercial Distribution

  • 10889981087272 ()

  • 14mm
92-0194

  • Orthopaedic implant driver

Sonoma - 10889981087265

Mini Drill 12mm
Seaspine Orthopedics Corporation
92-0192
In Commercial Distribution

  • 10889981087265 ()

  • 12mm
92-0192

  • Orthopaedic implant driver

Sonoma - 10889981087104

16mm Drill, Short
Seaspine Orthopedics Corporation
92-0163
In Commercial Distribution

  • 10889981087104 ()

  • 16mm
92-0163

  • Orthopaedic implant driver

Sonoma - 10889981087098

14mm Drill, Short
Seaspine Orthopedics Corporation
92-0162
In Commercial Distribution

  • 10889981087098 ()

  • 14mm
92-0162

  • Orthopaedic implant driver

Sonoma - 10889981087081

12mm Drill, Short
Seaspine Orthopedics Corporation
92-0161
In Commercial Distribution

  • 10889981087081 ()

  • 12mm
92-0161

  • Orthopaedic implant driver

Sonoma - 10889981086787

Cervical Screw Driver, Non-Tapered
Seaspine Orthopedics Corporation
92-0128
In Commercial Distribution

  • 10889981086787 ()
92-0128

  • Orthopaedic implant driver

Sonoma - 10889981086770

Cervical Screw Driver, Short
Seaspine Orthopedics Corporation
92-0127
In Commercial Distribution

  • 10889981086770 ()
92-0127

  • Orthopaedic implant driver

Sonoma - 10889981086725

Ball Tip Screw Driver
Seaspine Orthopedics Corporation
92-0121
In Commercial Distribution

  • 10889981086725 ()
92-0121

  • Orthopaedic implant driver

Zuma-C - 10889981086718

Cervical Screw Driver
Seaspine Orthopedics Corporation
92-0120
In Commercial Distribution

  • 10889981086718 ()
92-0120

  • Orthopaedic implant driver

Balboa - 10889981086558

3mm Screwdriver, Non-Tapered
Seaspine Orthopedics Corporation
91-9105
In Commercial Distribution

  • 10889981086558 ()

  • 3mm
91-9105

  • Surgical screwdriver, reusable

Balboa - 10889981086541

3mm Screwdriver, Modular
Seaspine Orthopedics Corporation
91-9104
In Commercial Distribution

  • 10889981086541 ()

  • 3mm
91-9104

  • Surgical screwdriver, reusable

Balboa - 10889981086527

3mm Screwdriver
Seaspine Orthopedics Corporation
91-9102
In Commercial Distribution

  • 10889981086527 ()

  • 3mm
91-9102

  • Surgical screwdriver, reusable

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
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