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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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Sierra™ - 10889981042752

Sierra Screw,4.5 Dia 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
50-4516
Not in Commercial Distribution

  • 10889981042752 ()

  • 4.5 Dia X 16mm
50-4516

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042745

Sierra Screw,4.5 Dia x 14mm. 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
50-4514
Not in Commercial Distribution

  • 10889981042745 ()

  • 4.5 Dia X 14mm
50-4514

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042738

Sierra Screw,4.5 Dia 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
50-4512
Not in Commercial Distribution

  • 10889981042738 ()

  • 4.5 Dia X 12mm
50-4512

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042721

Sierra Screw,4.5 Dia x 10mm. 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
50-4510
In Commercial Distribution

  • 10889981042721 ()

  • 4.5 Dia X 10mm
50-4510

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042714

Sierra Screw,4.5 Dia x 8mm. 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
50-4508
Not in Commercial Distribution

  • 10889981042714 ()

  • 4.5 Dia X 8mm
50-4508

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042707

Sierra Screw, 04.0 x 40mm. 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
50-4040
Not in Commercial Distribution

  • 10889981042707 ()

  • 4.0 Dia X 40mm
50-4040

  • Cannulated surgical drill bit, single-use

Mariner MIS - 10889981304843

Mariner MIS Navigation Tray SS, Level 1
SEASPINE ORTHOPEDICS CORPORATION
MM3-100045
In Commercial Distribution

  • 10889981304843 ()
MM3-100045

  • Instrument tray, reusable

NorthStar - 10889981304782

Straight Ti Rod, 4.0mm x 300mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-504004
In Commercial Distribution

  • 10889981304782 ()
PC1-504004

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

NorthStar - 10889981304775

Straight Ti Rod, 3.5mm x 300mm
SEASPINE ORTHOPEDICS CORPORATION
PC1-503504
In Commercial Distribution

  • 10889981304775 ()
PC1-503504

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

Daytona® Small Stature - 10889981303181

Transition CoCr Rod, 4.5mm to 5.5mm, 500mm
SEASPINE ORTHOPEDICS CORPORATION
76-9150
In Commercial Distribution

  • 10889981303181 ()
76-9150

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

Specials - 10889981303167

Tab Remover, Daytona
SEASPINE ORTHOPEDICS CORPORATION
SR-0867
In Commercial Distribution

  • 10889981303167 ()
SR-0867

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Mariner Deformity - 10889981298401

Iliac Tap, Cannulated, Navigated, 12.5mm
SEASPINE ORTHOPEDICS CORPORATION
MD2-213125
In Commercial Distribution

  • 10889981298401 ()
MD2-213125

  • Bone tap, reusable

Mariner Deformity - 10889981298395

Iliac Tap, Cannulated, Navigated, 12.0mm
SEASPINE ORTHOPEDICS CORPORATION
MD2-213120
In Commercial Distribution

  • 10889981298395 ()
MD2-213120

  • Bone tap, reusable

Mariner Deformity - 10889981298388

Iliac Tap, Cannulated, Navigated, 11.5mm
SEASPINE ORTHOPEDICS CORPORATION
MD2-213115
In Commercial Distribution

  • 10889981298388 ()
MD2-213115

  • Bone tap, reusable

Mariner Deformity - 10889981298371

Iliac Tap, Cannulated, Navigated, 11.0mm
SEASPINE ORTHOPEDICS CORPORATION
MD2-213110
In Commercial Distribution

  • 10889981298371 ()
MD2-213110

  • Bone tap, reusable

Mariner Deformity - 10889981298364

Iliac Tap, Cannulated, Navigated, 10.5mm
SEASPINE ORTHOPEDICS CORPORATION
MD2-213105
In Commercial Distribution

  • 10889981298364 ()
MD2-213105

  • Bone tap, reusable

Mariner Deformity - 10889981298357

Iliac Tap, Cannulated, Navigated, 10.0mm
SEASPINE ORTHOPEDICS CORPORATION
MD2-213100
In Commercial Distribution

  • 10889981298357 ()
MD2-213100

  • Bone tap, reusable

Mariner Deformity - 10889981298340

Iliac Tap, Cannulated, Navigated, 9.5mm
SEASPINE ORTHOPEDICS CORPORATION
MD2-213095
In Commercial Distribution

  • 10889981298340 ()
MD2-213095

  • Bone tap, reusable

Mariner Deformity - 10889981298333

Iliac Tap, Cannulated, Navigated, 9.0mm
SEASPINE ORTHOPEDICS CORPORATION
MD2-213090
In Commercial Distribution

  • 10889981298333 ()
MD2-213090

  • Bone tap, reusable

Mariner Deformity - 10889981298296

Iliac Tap, Cannulated, Navigated, 7.0mm
SEASPINE ORTHOPEDICS CORPORATION
MD2-213070
In Commercial Distribution

  • 10889981298296 ()
MD2-213070

  • Bone tap, reusable

Mariner Deformity - 10889981298005

Adjustable Locking Screwdriver, Tri-Flat, Short
SEASPINE ORTHOPEDICS CORPORATION
MD2-102014
In Commercial Distribution

  • 10889981298005 ()
MD2-102014

  • Orthopaedic implant inserter/extractor, reusable

Mariner Deformity - 10889981297992

Adjustable Locking Screwdriver, Navigated
SEASPINE ORTHOPEDICS CORPORATION
MD2-102009
In Commercial Distribution

  • 10889981297992 ()
MD2-102009

  • Orthopaedic implant driver

Mariner Deformity - 10889981297008

Closed Polyaxial Screwdriver
SEASPINE ORTHOPEDICS CORPORATION
MD2-102010
In Commercial Distribution

  • 10889981297008 ()
MD2-102010

  • Orthopaedic implant driver

Mariner Deformity - 10889981296155

Inline Reducer
SEASPINE ORTHOPEDICS CORPORATION
MD2-103004
In Commercial Distribution

  • 10889981296155 ()
MD2-103004

  • Orthopaedic rod reducer

Mariner Deformity - 10889981296148

Pistol Reducer, Single Pull
SEASPINE ORTHOPEDICS CORPORATION
MD2-103003
In Commercial Distribution

  • 10889981296148 ()
MD2-103003

  • Orthopaedic rod reducer

Mariner Deformity - 10889981295288

Adjustable Locking Screwdriver
SEASPINE ORTHOPEDICS CORPORATION
MD2-102008
In Commercial Distribution

  • 10889981295288 ()
MD2-102008

  • Orthopaedic implant driver

Mariner Deformity - 10889981295240

Thoracic Probe, Straight, Sharp, Navigated
SEASPINE ORTHOPEDICS CORPORATION
MD2-101018
In Commercial Distribution

  • 10889981295240 ()
MD2-101018

  • Abdominal/ENT/orthopaedic surgical probe, reusable

Mariner Deformity - 10889981295233

Iliac Probe, Straight, Sharp, Navigated
SEASPINE ORTHOPEDICS CORPORATION
MD2-101016
In Commercial Distribution

  • 10889981295233 ()
MD2-101016

  • Abdominal/ENT/orthopaedic surgical probe, reusable

Mariner Deformity - 10889981295226

Iliac Probe, Straight, Blunt, Navigated
SEASPINE ORTHOPEDICS CORPORATION
MD2-101014
In Commercial Distribution

  • 10889981295226 ()
MD2-101014

  • Abdominal/ENT/orthopaedic surgical probe, reusable

Mariner Deformity - 10889981295189

Iliac Tap, Navigated, 12.5mm
SEASPINE ORTHOPEDICS CORPORATION
MD2-211125
In Commercial Distribution

  • 10889981295189 ()
MD2-211125

  • Bone tap, reusable

Mariner Deformity - 10889981295172

Iliac Tap, Navigated, 12.0mm
SEASPINE ORTHOPEDICS CORPORATION
MD2-211120
In Commercial Distribution

  • 10889981295172 ()
MD2-211120

  • Bone tap, reusable

Mariner Deformity - 10889981295165

Iliac Tap, Navigated, 11.5mm
SEASPINE ORTHOPEDICS CORPORATION
MD2-211115
In Commercial Distribution

  • 10889981295165 ()
MD2-211115

  • Bone tap, reusable

Mariner Deformity - 10889981295158

Iliac Tap, Navigated, 11.0mm
SEASPINE ORTHOPEDICS CORPORATION
MD2-211110
In Commercial Distribution

  • 10889981295158 ()
MD2-211110

  • Bone tap, reusable

Mariner Deformity - 10889981295141

Iliac Tap, Navigated, 10.5mm
SEASPINE ORTHOPEDICS CORPORATION
MD2-211105
In Commercial Distribution

  • 10889981295141 ()
MD2-211105

  • Bone tap, reusable

Mariner Deformity - 10889981295134

Iliac Tap, Navigated, 10.0mm
SEASPINE ORTHOPEDICS CORPORATION
MD2-211100
In Commercial Distribution

  • 10889981295134 ()
MD2-211100

  • Bone tap, reusable

Mariner Deformity - 10889981295127

Iliac Tap, Navigated, 9.5mm
SEASPINE ORTHOPEDICS CORPORATION
MD2-211095
In Commercial Distribution

  • 10889981295127 ()
MD2-211095

  • Bone tap, reusable

Mariner Deformity - 10889981295110

Iliac Tap, Navigated, 9.0mm
SEASPINE ORTHOPEDICS CORPORATION
MD2-211090
In Commercial Distribution

  • 10889981295110 ()
MD2-211090

  • Bone tap, reusable

Mariner Deformity - 10889981295103

Iliac Tap, Navigated, 8.5mm
SEASPINE ORTHOPEDICS CORPORATION
MD2-211085
In Commercial Distribution

  • 10889981295103 ()
MD2-211085

  • Bone tap, reusable

Mariner Deformity - 10889981295097

Iliac Tap, Navigated, 8.0mm
SEASPINE ORTHOPEDICS CORPORATION
MD2-211080
In Commercial Distribution

  • 10889981295097 ()
MD2-211080

  • Bone tap, reusable

Mariner Deformity - 10889981295080

Iliac Tap, Navigated, 7.5mm
SEASPINE ORTHOPEDICS CORPORATION
MD2-211075
In Commercial Distribution

  • 10889981295080 ()
MD2-211075

  • Bone tap, reusable
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