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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™ - 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

NA - 06009544015253

Instrument, Unigrip Driver, Wrench Insert, Short
SOUTHERN IMPLANTS (PTY) LTD
I-WI-UG-S
In Commercial Distribution

  • 06009544015253 ()


  • Surgical screwdriver, reusable

NA - 06009544015239

Instrument, Unigrip Driver, Wrench Insert, Long
SOUTHERN IMPLANTS (PTY) LTD
I-WI-UG-L
In Commercial Distribution

  • 06009544015239 ()


  • Surgical screwdriver, reusable

NA - 06009544015154

Instrument, Torx Driver, Wrench Insert, Long
SOUTHERN IMPLANTS (PTY) LTD
I-WI-SCS-L
In Commercial Distribution

  • 06009544015154 ()


  • Surgical screwdriver, reusable

NA - 06009544014867

Instrument, Wrench Converter for W&H Hex Tools, Ø7.0mm
SOUTHERN IMPLANTS (PTY) LTD
I-WI-CST
In Commercial Distribution

  • 06009544014867 ()


  • Surgical torque wrench adaptor

NA - 06009544014850

Instrument, Handpiece to Wrench Converter, Short
SOUTHERN IMPLANTS (PTY) LTD
I-WI-C-S
In Commercial Distribution

  • 06009544014850 ()


  • Surgical torque wrench adaptor

NA - 06009544014843

Instrument, Wrench Converter for W&H Hex Tools, Ø8.0mm
SOUTHERN IMPLANTS (PTY) LTD
I-WI-CNB
In Commercial Distribution

  • 06009544014843 ()


  • Surgical torque wrench adaptor

NA - 06009544014836

Instrument, Handpiece to Wrench Converter, Long
SOUTHERN IMPLANTS (PTY) LTD
I-WI-C-L
In Commercial Distribution

  • 06009544014836 ()


  • Surgical torque wrench adaptor

NA - 06009544014829

Instrument, Narrow Blade Driver, Wrench Insert, Short
SOUTHERN IMPLANTS (PTY) LTD
I-WI-BSN
In Commercial Distribution

  • 06009544014829 ()


  • Surgical screwdriver, reusable

NA - 06009544014812

Instrument, Blade Driver, Wrench Insert, Short
SOUTHERN IMPLANTS (PTY) LTD
I-WI-BS
In Commercial Distribution

  • 06009544014812 ()


  • Surgical screwdriver, reusable

NA - 06009544014805

Instrument, Blade Driver, Wrench Insert, Medium
SOUTHERN IMPLANTS (PTY) LTD
I-WI-BM
In Commercial Distribution

  • 06009544014805 ()


  • Surgical screwdriver, reusable

NA - 06009544014799

Instrument, Narrow Blade Driver, Wrench Insert, Long
SOUTHERN IMPLANTS (PTY) LTD
I-WI-BLN
In Commercial Distribution

  • 06009544014799 ()


  • Surgical screwdriver, reusable

NA - 06009544014782

Instrument, Blade Driver, Wrench Insert, Long
SOUTHERN IMPLANTS (PTY) LTD
I-WI-BL
In Commercial Distribution

  • 06009544014782 ()


  • Surgical screwdriver, reusable

NA - 06009544014775

Instrument, Abutment Driver, Wrench Insert
SOUTHERN IMPLANTS (PTY) LTD
I-WI-A
In Commercial Distribution

  • 06009544014775 ()


  • Surgical screwdriver, reusable

NA - 06009544014768

Instrument, 1.27mm Hex Driver, Wrench Insert, Short
SOUTHERN IMPLANTS (PTY) LTD
I-WI-27S
In Commercial Distribution

  • 06009544014768 ()


  • Surgical screwdriver, reusable

NA - 06009544014751

Instrument, 1.27mm Hex Driver, Wrench Insert, Medium
SOUTHERN IMPLANTS (PTY) LTD
I-WI-27M
In Commercial Distribution

  • 06009544014751 ()


  • Surgical screwdriver, reusable

NA - 06009544014744

Instrument, 1.27mm Hex Driver, Wrench Insert, Long
SOUTHERN IMPLANTS (PTY) LTD
I-WI-27L
In Commercial Distribution

  • 06009544014744 ()


  • Surgical screwdriver, reusable

NA - 06009544014737

Instrument, 1.22mm Hex Driver, Wrench Insert, Short
SOUTHERN IMPLANTS (PTY) LTD
I-WI-22S
In Commercial Distribution

  • 06009544014737 ()


  • Surgical screwdriver, reusable

NA - 06009544014720

Instrument, 1.22mm Hex Driver, Wrench Insert, Medium
SOUTHERN IMPLANTS (PTY) LTD
I-WI-22M
In Commercial Distribution

  • 06009544014720 ()


  • Surgical screwdriver, reusable

NA - 06009544014713

Instrument, 1.22mm Hex Driver, Wrench Insert, Long
SOUTHERN IMPLANTS (PTY) LTD
I-WI-22L
In Commercial Distribution

  • 06009544014713 ()


  • Surgical screwdriver, reusable

NA - 06009544014706

Instrument, 0.9mm Hex Driver, Wrench Insert
SOUTHERN IMPLANTS (PTY) LTD
I-WI-09
In Commercial Distribution

  • 06009544014706 ()


  • Surgical screwdriver, reusable

NA - 06009544014690

Instrument, Unigrip Driver, Short
SOUTHERN IMPLANTS (PTY) LTD
I-UGI-S
In Commercial Distribution

  • 06009544014690 ()


  • Surgical screwdriver, reusable

NA - 06009544014683

Instrument, Unigrip Driver, Medium
SOUTHERN IMPLANTS (PTY) LTD
I-UGI-M
In Commercial Distribution

  • 06009544014683 ()


  • Surgical screwdriver, reusable

NA - 06009544014676

Instrument, Unigrip Driver, Long
SOUTHERN IMPLANTS (PTY) LTD
I-UGI-L
In Commercial Distribution

  • 06009544014676 ()


  • Surgical screwdriver, reusable
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