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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™ - 10889981042479

Sierra Screw, 03.5 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
50-3528
In Commercial Distribution

  • 10889981042479 ()

  • 3.5 Dia X 28mm
50-3528

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042462

Sierra Screw, 03.5 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
50-3526
In Commercial Distribution

  • 10889981042462 ()

  • 3.5 Dia X 26mm
50-3526

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042455

Sierra Screw, 03.5 x 24mm. 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
50-3524
In Commercial Distribution

  • 10889981042455 ()

  • 3.5 Dia X 24mm
50-3524

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042448

Sierra Screw, 03.5 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
50-3522
In Commercial Distribution

  • 10889981042448 ()

  • 3.5 Dia X 22mm
50-3522

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042431

Sierra Screw, 03.5 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
50-3520
In Commercial Distribution

  • 10889981042431 ()

  • 3.5 Dia X 20mm
50-3520

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042424

Sierra Screw, 03.5 x 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
50-3518
In Commercial Distribution

  • 10889981042424 ()

  • 3.5 Dia X 18mm
50-3518

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042417

Sierra Screw, 03.5 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
50-3516
In Commercial Distribution

  • 10889981042417 ()

  • 3.5 Dia X 16mm
50-3516

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042400

Sierra Screw, 03.5 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
50-3514
In Commercial Distribution

  • 10889981042400 ()

  • 3.5 Dia X 14mm
50-3514

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042394

Sierra Screw, 03.5 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
50-3512
In Commercial Distribution

  • 10889981042394 ()

  • 3.5 Dia X 12mm
50-3512

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042387

Sierra Screw, 03.5 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
50-3510
In Commercial Distribution

  • 10889981042387 ()

  • 3.5 Dia X 10mm
50-3510

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042332

Contoured Crossbar, Small, 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
50-2011
In Commercial Distribution

  • 10889981042332 ()

  • 3.5
50-2011

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042318

Closed Lateral Connector, 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
50-0035
In Commercial Distribution

  • 10889981042318 ()

  • 3.5
50-0035

  • Cannulated surgical drill bit, single-use

NA - 06009544032533

Instrument, 1.22mm/1.27mm Universal Hex Driver, Wrench Insert, Medium
SOUTHERN IMPLANTS (PTY) LTD
I-WI-22U-M
In Commercial Distribution

  • 06009544032533 ()


  • Surgical screwdriver, reusable

NA - 06009544032519

Instrument, 1.22mm/1.27mm Universal Hex Driver, Handpiece Insert, Short
SOUTHERN IMPLANTS (PTY) LTD
I-HHD-22U-S
In Commercial Distribution

  • 06009544032519 ()


  • Surgical screwdriver, reusable

NA - 06009544032502

Instrument, 1.22mm/1.27mm Universal Hex Driver, Handpiece Insert, Medium
SOUTHERN IMPLANTS (PTY) LTD
I-HHD-22U-M
In Commercial Distribution

  • 06009544032502 ()


  • Surgical screwdriver, reusable

NA - 06009544032496

Instrument, 1.22mm/1.27mm Universal Hex Driver, Handpiece Insert, Long
SOUTHERN IMPLANTS (PTY) LTD
I-HHD-22U-L
In Commercial Distribution

  • 06009544032496 ()


  • Surgical screwdriver, reusable

NA - 06009544032489

Instrument, 1.22mm/1.27mm Universal Hex Driver, Short
SOUTHERN IMPLANTS (PTY) LTD
I-HD-22U-S
In Commercial Distribution

  • 06009544032489 ()


  • Surgical screwdriver, reusable

NA - 06009544032465

Instrument, 1.22mm/1.27mm Universal Hex Driver, Long
SOUTHERN IMPLANTS (PTY) LTD
I-HD-22U-L
In Commercial Distribution

  • 06009544032465 ()


  • Surgical screwdriver, reusable

Sierra™ - 10889981042950

Occipital Screw, 11mm. 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
50-5011
In Commercial Distribution

  • 10889981042950 ()

  • 11mm
50-5011

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042936

Occipital Screw, 9mm. 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
50-5009
In Commercial Distribution

  • 10889981042936 ()

  • 9mm
50-5009

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042912

Occipital Screw, 7mm. 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
50-5007
In Commercial Distribution

  • 10889981042912 ()

  • 7mm
50-5007

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042882

Sierra Screw,4.5 Dia x 45mm. 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
50-4545
Not in Commercial Distribution

  • 10889981042882 ()

  • 4.5 Dia X 45mm
50-4545

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042820

Sierra Screw,4.5 Dia 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
50-4530
Not in Commercial Distribution

  • 10889981042820 ()

  • 4.5 Dia X 30mm
50-4530

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042790

Sierra Screw,4.5 Dia x 24mm. 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
50-4524
In Commercial Distribution

  • 10889981042790 ()

  • 4.5 Dia X 24mm
50-4524

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042776

Sierra Screw,4.5 Dia 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
50-4520
In Commercial Distribution

  • 10889981042776 ()

  • 4.5 Dia X 20mm
50-4520

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042769

Sierra Screw,4.5 Dia x 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
50-4518
Not in Commercial Distribution

  • 10889981042769 ()

  • 4.5 Dia X 18mm
50-4518

  • Cannulated surgical drill bit, single-use

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
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