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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™ - 10889981043063

Rod, 3.5 x 30mm. 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
50-6030
Not in Commercial Distribution

  • 10889981043063 ()

  • 3.5 X 30mm
50-6030

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043056

Rod, 3.5 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
50-6020
Not in Commercial Distribution

  • 10889981043056 ()

  • 3.5 X 20mm
50-6020

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043049

Occipital Screw, 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
50-5020
Not in Commercial Distribution

  • 10889981043049 ()

  • 20mm
50-5020

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043032

Occipital Screw, 19mm. 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
50-5019
Not in Commercial Distribution

  • 10889981043032 ()

  • 19mm
50-5019

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043025

Occipital Screw, 18mm. 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
50-5018
Not in Commercial Distribution

  • 10889981043025 ()

  • 18mm
50-5018

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043018

Occipital Screw, 17mm. 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
50-5017
Not in Commercial Distribution

  • 10889981043018 ()

  • 17mm
50-5017

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043001

Occipital Screw, 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
50-5016
Not in Commercial Distribution

  • 10889981043001 ()

  • 16mm
50-5016

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042998

Occipital Screw, 15mm. 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
50-5015
Not in Commercial Distribution

  • 10889981042998 ()

  • 15mm
50-5015

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042981

Occipital Screw, 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
50-5014
In Commercial Distribution

  • 10889981042981 ()

  • 14mm
50-5014

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042974

Occipital Screw, 13mm. 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
50-5013
In Commercial Distribution

  • 10889981042974 ()

  • 13mm
50-5013

  • Cannulated surgical drill bit, single-use

MEDALLION(TM) TROCH BOLT DRIVER - 00880304640375

No Description
Biomet Orthopedics, LLC
71-207014
In Commercial Distribution

  • 00880304640375 ()
71-207014

  • Orthopaedic implant driver

Specials - 10889981435196

Straight Driver, Short
Seaspine Orthopedics Corporation
SR-1371
In Commercial Distribution

  • 10889981435196 ()
SR-1371

  • Orthopaedic implant driver

Specials - 10889981403577

Lattus Offset Driver
Seaspine Orthopedics Corporation
SR-1354
In Commercial Distribution

  • 10889981403577 ()
SR-1354

  • Self-retaining surgical retractor, reusable

MAX VPC™CANNULATED DRIVER HEX AO - 00880304814271

No Description
Biomet Orthopedics, LLC
212001240
In Commercial Distribution

  • 00880304814271 ()

  • 2.5MM
212001240

  • Surgical screwdriver, reusable

MAX VPC™CANNULATED DRIVER HEX AO - 00880304814264

No Description
Biomet Orthopedics, LLC
212001230
In Commercial Distribution

  • 00880304814264 ()

  • 2.0MM
212001230

  • Surgical screwdriver, reusable

MAX VPC™CANNULATED DRIVER HEX AO - 00880304814257

No Description
Biomet Orthopedics, LLC
212001225
In Commercial Distribution

  • 00880304814257 ()

  • 1.5MM
212001225

  • Surgical screwdriver, reusable

MAX VPCSOLID DRIVER HEX AO - 00880304805064

No Description
Biomet Orthopedics, LLC
231201340
In Commercial Distribution

  • 00880304805064 ()

  • 2.5MM
231201340

  • Surgical screwdriver, reusable

MAX VPCCANNULATED DRIVER HEX AO - 00880304805057

No Description
Biomet Orthopedics, LLC
231201240
In Commercial Distribution

  • 00880304805057 ()

  • 2.5MM
231201240

  • Surgical screwdriver, reusable

MAX VPCSOLID DRIVER HEX AO - 00880304804869

No Description
Biomet Orthopedics, LLC
231201330
In Commercial Distribution

  • 00880304804869 ()

  • 2.0MM
231201330

  • Surgical screwdriver, reusable

MAX VPCCANNULATED DRIVER HEX AO - 00880304804852

No Description
Biomet Orthopedics, LLC
231201230
In Commercial Distribution

  • 00880304804852 ()

  • 2.0MM
231201230

  • Surgical screwdriver, reusable

MAX VPCSOLID DRIVER HEX AO - 00880304804692

No Description
Biomet Orthopedics, LLC
231201325
In Commercial Distribution

  • 00880304804692 ()

  • 1.5MM
231201325

  • Surgical screwdriver, reusable

MAX VPCCANNULATED DRIVER HEX AO - 00880304804685

No Description
Biomet Orthopedics, LLC
231201225
In Commercial Distribution

  • 00880304804685 ()

  • 1.5MM
231201225

  • Surgical screwdriver, reusable

Specials - 10889987170398

4mm Driver
Seaspine Orthopedics Corporation
SR-0352
Not in Commercial Distribution

  • 10889987170398 ()
SR-0352

  • Orthopaedic implant driver

HEXALOBULAR DRIVER DOUBLE MINI QUICK CONNECT - 00880304677050

No Description
Biomet Orthopedics, LLC
110018125
In Commercial Distribution

  • 00880304677050 ()

  • T6
110018125

  • Orthopaedic implant driver

ARCOS 3.5MM HEX DRIVER W/O HUDSON - 00880304673717

No Description
Biomet Orthopedics, LLC
31-301880
In Commercial Distribution

  • 00880304673717 ()
31-301880

  • Surgical screwdriver, reusable

Specials - 10889987164434

Split Tip Hex Driver, 4mm
Seaspine Orthopedics Corporation
SR-0337
Not in Commercial Distribution

  • 10889987164434 ()
SR-0337

  • Orthopaedic implant driver

Special - 10889981365257

Angled Driver, Short, Retention Rod
Seaspine Orthopedics Corporation
SR-1324
In Commercial Distribution

  • 10889981365257 ()
SR-1324

  • Orthopaedic implant driver

Special - 10889981333249

Angled Driver, Retention Rod
Seaspine Orthopedics Corporation
SR-1271
In Commercial Distribution

  • 10889981333249 ()
SR-1271

  • Orthopaedic implant driver

Special - 10889981332655

Set Screw Starter
Seaspine Orthopedics Corporation
SR-1303
In Commercial Distribution

  • 10889981332655 ()
SR-1303

  • Orthopaedic implant driver

Specials - 10889981331306

Adjustable Locking Screwdriver w/ Stryker-Hall End
Seaspine Orthopedics Corporation
SR-1293
In Commercial Distribution

  • 10889981331306 ()
SR-1293

  • Orthopaedic implant driver

Specials - 10889981331290

Closed Polyaxial Screwdriver w/ Stryker-Hall End
Seaspine Orthopedics Corporation
SR-1292
In Commercial Distribution

  • 10889981331290 ()
SR-1292

  • Orthopaedic implant driver

Specials - 10889981331160

Mariner Driver, Shortened w/o Spin Sleeve
Seaspine Orthopedics Corporation
SR-1287
In Commercial Distribution

  • 10889981331160 ()
SR-1287

  • Orthopaedic implant driver

Meridian - 10889981321789

Variable Angle Driver, T12
Seaspine Orthopedics Corporation
RA2-003035
In Commercial Distribution

  • 10889981321789 ()
RA2-003035

  • Orthopaedic implant driver

Meridian - 10889981321758

Angled Driver, T12
Seaspine Orthopedics Corporation
RA2-003032
In Commercial Distribution

  • 10889981321758 ()
RA2-003032

  • Orthopaedic implant driver

Meridian - 10889981321741

Straight Driver, T12
Seaspine Orthopedics Corporation
RA2-003031
In Commercial Distribution

  • 10889981321741 ()
RA2-003031

  • Orthopaedic implant driver

Specials - 10889981321659

Deformity Driver w/ Modified Connection
Seaspine Orthopedics Corporation
SR-1159
In Commercial Distribution

  • 10889981321659 ()
SR-1159

  • Orthopaedic implant driver

Specials - 10889981321581

Tulip Stab and Grab Driver
Seaspine Orthopedics Corporation
SR-1172
In Commercial Distribution

  • 10889981321581 ()
SR-1172

  • Orthopaedic implant driver

Specials - 10889981321499

Depth Stop, Extended Driver Sleeve, 20mm
Seaspine Orthopedics Corporation
SR-1171-20
In Commercial Distribution

  • 10889981321499 ()
SR-1171-20

  • Orthopaedic implantation sleeve, reusable

Specials - 10889981321482

Depth Stop, Extended Driver Sleeve, 5mm
Seaspine Orthopedics Corporation
SR-1171-05
In Commercial Distribution

  • 10889981321482 ()
SR-1171-05

  • Orthopaedic implantation sleeve, reusable

Specials - 10889981321239

Shoreline Flex Driver
Seaspine Orthopedics Corporation
SR-1010
In Commercial Distribution

  • 10889981321239 ()
SR-1010

  • Orthopaedic implant driver

Specials - 10889981326012

Sleeve, MIS Locking Navigation Driver
Seaspine Orthopedics Corporation
SR-1183-20
In Commercial Distribution

  • 10889981326012 ()
SR-1183-20

  • Orthopaedic implantation sleeve, reusable

Specials - 10889981326005

MIS Locking Navigation Driver
Seaspine Orthopedics Corporation
SR-1183
In Commercial Distribution

  • 10889981326005 ()
SR-1183

  • Orthopaedic implant driver

Specials - 10889981325350

Shortened Reduction Driver, Tri-Flat
Seaspine Orthopedics Corporation
SR-1230
In Commercial Distribution

  • 10889981325350 ()
SR-1230

  • Orthopaedic implant driver

Specials - 10889981325077

Screw Shank Driver, Reduced Thread
Seaspine Orthopedics Corporation
SR-1203
In Commercial Distribution

  • 10889981325077 ()
SR-1203

  • Orthopaedic implant driver

Specials - 10889981325060

Poly Screwdriver w/ Modified Tip
Seaspine Orthopedics Corporation
SR-1207
In Commercial Distribution

  • 10889981325060 ()
SR-1207

  • Orthopaedic implant driver

VECTOR TAS - 10889989000051

VECTOR TAS DRIVER TIP 22MM - Qty 2
ORMCO CORPORATION
601-0012
In Commercial Distribution

  • 10889989000051 ()
  • 00889989000054 ()

  • 22mm Driver Tip Diameter


  • Orthodontic anchoring screw

VECTOR TAS - 10889989000044

VECTOR TAS DRIVER TIP 40MM - Qty 2
ORMCO CORPORATION
601-0011
In Commercial Distribution

  • 10889989000044 ()
  • 00889989000047 ()

  • 40mm Driver Tip Diameter


  • Orthodontic anchoring screw

Mariner MCT - 10889987170114

Cortical Screw Shank Driver, Long
Seaspine Orthopedics Corporation
MC2-003012
Not in Commercial Distribution

  • 10889987170114 ()
MC2-003012

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Mariner MCT - 10889987170107

Cortical Screw Shank Driver, Short
Seaspine Orthopedics Corporation
MC2-003011
Not in Commercial Distribution

  • 10889987170107 ()
MC2-003011

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Mariner MCT - 10889987170091

Cortical Screw Shank Driver
Seaspine Orthopedics Corporation
MC2-003010
Not in Commercial Distribution

  • 10889987170091 ()
MC2-003010

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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