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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™ - 10889981042554

Sierra Screw, 04.0 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
50-4010
In Commercial Distribution

  • 10889981042554 ()

  • 4.0 Dia X 10mm
50-4010

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042547

Sierra Screw, 04.0 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
50-4008
Not in Commercial Distribution

  • 10889981042547 ()

  • 4.0 Dia X 8mm
50-4008

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042530

Sierra Screw, 03.5 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
50-3540
Not in Commercial Distribution

  • 10889981042530 ()

  • 3.5 Dia X 40mm
50-3540

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042523

Sierra Screw, 03.5 x 38mm. 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
50-3538
Not in Commercial Distribution

  • 10889981042523 ()

  • 3.5 Dia X 38mm
50-3538

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042516

Sierra Screw, 03.5 x 36mm. 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
50-3536
Not in Commercial Distribution

  • 10889981042516 ()

  • 3.5 Dia X 36mm
50-3536

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042509

Sierra Screw, 03.5 x 34mm. 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
50-3534
Not in Commercial Distribution

  • 10889981042509 ()

  • 3.5 Dia X 34mm
50-3534

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042493

Sierra Screw, 03.5 x 32mm. 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
50-3532
In Commercial Distribution

  • 10889981042493 ()

  • 3.5 Dia X 32mm
50-3532

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042486

Sierra Screw, 03.5 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
50-3530
In Commercial Distribution

  • 10889981042486 ()

  • 3.5 Dia X 30mm
50-3530

  • Cannulated surgical drill bit, single-use

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™ - 10889981042370

Sierra Screw, 03.5 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
50-3508
Not in Commercial Distribution

  • 10889981042370 ()

  • 3.5 Dia X 8mm
50-3508

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042363

Contoured Crossbar, Xlarge, 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
50-2014
In Commercial Distribution

  • 10889981042363 ()

  • 3.5
50-2014

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042356

Contoured Crossbar, Large, 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
50-2013
In Commercial Distribution

  • 10889981042356 ()

  • 3.5
50-2013

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042349

Contoured Crossbar, Medium, 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
50-2012
In Commercial Distribution

  • 10889981042349 ()

  • 3.5
50-2012

  • 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™ - 10889981042325

Sierra Locking Cap. 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
50-1000
In Commercial Distribution

  • 10889981042325 ()
50-1000

  • 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

HU-FRIEDY - 10889950079673

#1 MEAD IMMUNITY MALLET - GERMAN STYLE
HU-FRIEDY MFG. CO., LLC
MAL1E
In Commercial Distribution

  • 10889950079673 ()
MAL1E

  • Surgical mallet

Visualase Anchor Bolt Driver Guide - 00873263009130

Visualase Anchor Bolt Driver Guide for ROSA ONE (1) Anchor Bolt Driver Guide for ROSA ONE Brain
FHC, INC.
9736542-00913
In Commercial Distribution

  • 00873263009130 ()
9736542

  • Neurological stereotactic surgery system

Visualase Anchor Bolt Driver Guide - 00873263009123

Visualase Anchor Bolt Guide for Leksell (1) Anchor Bolt Driver Guide for Leksell Coordinate Frame
FHC, INC.
9736541-00912
In Commercial Distribution

  • 00873263009123 ()
9736541

  • Neurological stereotactic surgery system

Visualase Anchor Bolt Driver Guide - 00873263009116

Visualase Anchor Bolt Driver Guide for CRW (1) Anchor Bolt Driver Guide for CRW Stereotactic System
FHC, INC.
9736540-00911
In Commercial Distribution

  • 00873263009116 ()
9736540

  • Neurological stereotactic surgery system

Visualase Anchor Bolt Driver - 00873263009109

Visualase Anchor Bolt Driver (1) Anchor Bolt Driver
FHC, INC.
9736539-00910
In Commercial Distribution

  • 00873263009109 ()
9736539

  • Neurological stereotactic surgery system

WayPoint™ Implantation Kit - 00873263007082

microTargeting WayPoint Implantation Kit, Reusable Components Contains: Sterilization Case Combination Bit WayPoint Driver 4mm
FHC, INC.
66-WP-RU-00708
In Commercial Distribution

  • 00873263007082 ()
66-WP-RU

  • Neurological stereotactic surgery system

Medtronic Reusable Instruments - 00673978159881

BOLT DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X847-327
In Commercial Distribution

  • 00673978159881 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00673978158532

CLAMSHELL SCREWDRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X808-531
In Commercial Distribution

  • 00673978158532 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00673978156897

PYRAMESH MOD. END RING DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X1298-011
In Commercial Distribution

  • 00673978156897 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00673978154657

SCREWDRIVER X1198-019 MAS SHAFT 11 INCH
MEDTRONIC SOFAMOR DANEK, INC.
X1198-019
In Commercial Distribution

  • 00673978154657 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00673978151786

5.5MM FIXED SCRW DRIVER M8 EXT
MEDTRONIC SOFAMOR DANEK, INC.
X1098-023
In Commercial Distribution

  • 00673978151786 ()


  • Surgical screwdriver, reusable

Medtronic Reusable Instruments - 00673978151274

M10 DRIVER SHAFT, T30 DRIVE
MEDTRONIC SOFAMOR DANEK, INC.
X1097-044
In Commercial Distribution

  • 00673978151274 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00673978147307

FACET LOCATOR
MEDTRONIC SOFAMOR DANEK, INC.
X0898-005
In Commercial Distribution

  • 00673978147307 ()


  • External spinal fixation system

Medtronic Reusable Instruments - 00673978147154

SCREWDRIVER X0897-018 AXIS SHAFT 14''
MEDTRONIC SOFAMOR DANEK, INC.
X0897-018
In Commercial Distribution

  • 00673978147154 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00673978145976

SCREWDRIVER X0892-006 VAR ANGL 10.5 INCH
MEDTRONIC SOFAMOR DANEK, INC.
X0892-006
In Commercial Distribution

  • 00673978145976 ()


  • Orthopaedic implant driver
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