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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™ - 10889981043131

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
50-6120
In Commercial Distribution

  • 10889981043131 ()

  • 3.5 X 20mm
50-6120

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043117

Rod, 3.5 x 80mm. 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
50-6080
In Commercial Distribution

  • 10889981043117 ()

  • 3.5 X 80mm
50-6080

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043087

Rod, 3.5 x 50mm. 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
50-6050
In Commercial Distribution

  • 10889981043087 ()

  • 3.5 X 50mm
50-6050

  • 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™ - 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™ - 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

Screwdriver Shaft, Hexagonal T6 - 06902139112439

No Description
Double Medical Technology Inc.
111301500
In Commercial Distribution

  • 06902139112439 ()
111301500

  • Surgical screwdriver, reusable

Screwdriver, starDrive, cannulated, T25 - 06902139112330

No Description
Double Medical Technology Inc.
111226200
In Commercial Distribution

  • 06902139112330 ()
111226200

  • Surgical screwdriver, reusable

Screwdriver Shaft, Stardrive, T25 - 06902139112255

No Description
Double Medical Technology Inc.
111225400
In Commercial Distribution

  • 06902139112255 ()
111225400

  • Surgical screwdriver, reusable

Slide Hammer - 06902139112019

No Description
Double Medical Technology Inc.
111193200
In Commercial Distribution

  • 06902139112019 ()
111193200

  • Surgical mallet

Screwdriver, hexagonal, with universal joint - 06902139111814

No Description
Double Medical Technology Inc.
110304100
In Commercial Distribution

  • 06902139111814 ()
110304100

  • Surgical screwdriver, reusable

Screwdriver Shaft for End Cap - 06902139111760

No Description
Double Medical Technology Inc.
110303600
In Commercial Distribution

  • 06902139111760 ()
110303600

  • Surgical screwdriver, reusable

Hammer - 06902139111654

No Description
Double Medical Technology Inc.
110302400
In Commercial Distribution

  • 06902139111654 ()
110302400

  • Surgical mallet

Screwdriver,cannulated,Φ5.0 - 06902139111531

No Description
Double Medical Technology Inc.
110301200
In Commercial Distribution

  • 06902139111531 ()
110301200

  • Surgical screwdriver, reusable

Screwdriver, hexagonal, Φ4.0 - 06902139111524

No Description
Double Medical Technology Inc.
110301100
In Commercial Distribution

  • 06902139111524 ()
110301100

  • Surgical screwdriver, reusable

Screwdriver, Hexagonal - 06902139111401

No Description
Double Medical Technology Inc.
110211100
In Commercial Distribution

  • 06902139111401 ()
110211100

  • Surgical screwdriver, reusable

Screwdriver, Hexagonal, Cannulated - 06902139111395

No Description
Double Medical Technology Inc.
110211000
In Commercial Distribution

  • 06902139111395 ()
110211000

  • Surgical screwdriver, reusable

Screwdriver, Hexagonal, Cannulated, φ4.0 - 06902139111302

No Description
Double Medical Technology Inc.
110201100
In Commercial Distribution

  • 06902139111302 ()
110201100

  • Surgical screwdriver, reusable

Screwdriver, Hexagonal, Cannulated, φ2.5 - 06902139111159

No Description
Double Medical Technology Inc.
110190800
In Commercial Distribution

  • 06902139111159 ()
110190800

  • Surgical screwdriver, reusable

Screwdriver Shaft, hexagonal, φ2.5 - 06902139110640

No Description
Double Medical Technology Inc.
110041700
In Commercial Distribution

  • 06902139110640 ()
110041700

  • Surgical screwdriver, reusable

Torque Indicating Screwdriver, 1.5N-m - 06902139110497

No Description
Double Medical Technology Inc.
110040800
In Commercial Distribution

  • 06902139110497 ()
110040800

  • Surgical screwdriver, reusable

SW 2.5 Hexagonal Screwdriver Shaft - 06902139110350

No Description
Double Medical Technology Inc.
110023300
In Commercial Distribution

  • 06902139110350 ()
110023300

  • Surgical screwdriver, reusable

SW2.5 Hexagonal Screwdriver - 06902139110336

No Description
Double Medical Technology Inc.
110023100
In Commercial Distribution

  • 06902139110336 ()
110023100

  • Surgical screwdriver, reusable

Oxford Uni Knee System - 00880304525658

No Description
Biomet Uk Ltd
32-422760
In Commercial Distribution

  • 00880304525658 ()
32-422760

  • Surgical mallet

3.5MM DRIVER (T15) - 00880304523616

No Description
Biomet Orthopedics, LLC
36505
In Commercial Distribution

  • 00880304523616 ()

  • 3.5MM
36505

  • Surgical screwdriver, reusable

5MM CONNECTING SCREW INSERTER - 00880304523456

No Description
Biomet Orthopedics, LLC
41003
In Commercial Distribution

  • 00880304523456 ()

  • 5MM
41003

  • Surgical screwdriver, reusable

DRIVER BUSHING - 00880304519909

No Description
Biomet Orthopedics, LLC
24295
In Commercial Distribution

  • 00880304519909 ()
24295

  • Surgical drill guide, reusable

NorthStar - 10889981199760

Modular OCC Driver Tip
Seaspine Orthopedics Corporation
PC2-300006
In Commercial Distribution

  • 10889981199760 ()
PC2-300006

  • Orthopaedic implant driver

NorthStar - 10889981199753

OCC Angled DTS Driver
Seaspine Orthopedics Corporation
PC2-300004
In Commercial Distribution

  • 10889981199753 ()
PC2-300004

  • Orthopaedic implant driver
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