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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18/20 PLUG
MEDTRONIC SOFAMOR DANEK, INC.
Y0999-018
Not in Commercial Distribution

  • 00681490000543 ()


  • Surgical screwdriver, reusable
16/26 PLUG
MEDTRONIC SOFAMOR DANEK, INC.
Y0999-017
Not in Commercial Distribution

  • 00681490000536 ()


  • Surgical screwdriver, reusable
16/23 PLUG
MEDTRONIC SOFAMOR DANEK, INC.
Y0999-016
Not in Commercial Distribution

  • 00681490000529 ()


  • Surgical screwdriver, reusable
16/20 PLUG
MEDTRONIC SOFAMOR DANEK, INC.
Y0999-015
Not in Commercial Distribution

  • 00681490000512 ()


  • Surgical screwdriver, reusable
ACC 963-850 FIGHTER INSERT/REMOVAL TOOL
MEDTRONIC NAVIGATION, INC.
963-850
In Commercial Distribution

  • 00681490917025 ()


  • Surgical screwdriver, reusable
INSTRUMENT 80615525 QC SCREW REMOVER
MEDTRONIC SOFAMOR DANEK, INC.
80615525
In Commercial Distribution

  • 00681490912310 ()


  • Surgical screwdriver, reusable
INSTR 8361023 3D 7 32 STSCR SCKT DR 3D
MEDTRONIC SOFAMOR DANEK, INC.
8361023
In Commercial Distribution

  • 00681490909563 ()


  • Orthopaedic implant driver
T-HANDLE W/ MINI HUDSON QC
MEDTRONIC SOFAMOR DANEK, INC.
X0101012
In Commercial Distribution

  • 00681490906753 ()


  • Orthopaedic implant driver
DRIVER 8001205 MOD SHAFT 1.6MM
MEDTRONIC PS MEDICAL, INC.
8001205
In Commercial Distribution

  • 00681490904384 ()


  • General internal orthopaedic fixation system implantation kit
M8 MAS DRIVER W/ BALL DETENT
MEDTRONIC SOFAMOR DANEK, INC.
X1000007
In Commercial Distribution

  • 00681490902250 ()


  • Orthopaedic implant driver
NON CANN. DRIVER W/2.5MM HEX
MEDTRONIC SOFAMOR DANEK, INC.
X0900023
In Commercial Distribution

  • 00681490902168 ()


  • Orthopaedic implant driver
M8 INST 8680926 SPLIT T25 DRIVER SHT
MEDTRONIC SOFAMOR DANEK, INC.
8680926
In Commercial Distribution

  • 00681490901482 ()


  • Surgical screwdriver, reusable
LOCKSCREW DRIVER W/MOD HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X1100015
In Commercial Distribution

  • 00681490570152 ()


  • Orthopaedic implant driver
HANDLE 9150046 TREPHINE DRIVER PEAR
MEDTRONIC SOFAMOR DANEK, INC.
9150046
In Commercial Distribution

  • 00681490542425 ()


  • Surgical instrument handle, non-torque-limiting
BLUEDIAMOND Octa 2.5/ Short
Megagen Implant Co. Ltd
AROFDRS
In Commercial Distribution

  • 00880029300387 ()
AROFDRS

  • Surgical screwdriver, reusable
M8 INST 8680052 M8 MULTI AXIAL SCRWDR
MEDTRONIC SOFAMOR DANEK, INC.
8680052
In Commercial Distribution

  • 00681490520010 ()


  • Surgical screwdriver, reusable
DRIVER 836-900 HEX 3.5MM WITH EGG HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
836-900
In Commercial Distribution

  • 00681490499477 ()


  • Orthopaedic implant driver
MOD. DUAL SCREWDRIVER SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
X0500022
In Commercial Distribution

  • 00681490489096 ()


  • Orthopaedic implant driver
INSTRUMENT 6860482 SCREWDRIVER
MEDTRONIC SOFAMOR DANEK, INC.
6860482
In Commercial Distribution

  • 00681490482653 ()


  • Surgical screwdriver, reusable
NYLON FACING FOR #1 MALLET GERMAN STYLE
HU-FRIEDY MFG. CO., LLC
PTNFM1E
Not in Commercial Distribution

  • 10889950106775 ()
PTNFM1E

  • Surgical mallet
No Description
Biomet Orthopedics, LLC
424417
In Commercial Distribution

  • 00880304009424 ()
424417

  • Surgical screwdriver, reusable
No Description
Biomet Orthopedics, LLC
424493
In Commercial Distribution

  • 00880304009417 ()
424493

  • Surgical screwdriver, reusable
No Description
Biomet Orthopedics, LLC
424495
In Commercial Distribution

  • 00880304009394 ()
424495

  • Surgical screwdriver, reusable
No Description
Biomet Orthopedics, LLC
31-476946
In Commercial Distribution

  • 00880304008984 ()
31-476946

  • Orthopaedic implant driver
Occipital Screw, 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
50-5012
In Commercial Distribution

  • 10889981042967 ()

  • 12mm
50-5012

  • Cannulated surgical drill bit, single-use
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
Occipital Screw, 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
50-5010
In Commercial Distribution

  • 10889981042943 ()

  • 10mm
50-5010

  • Cannulated surgical drill bit, single-use
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
Occipital Screw, 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
50-5008
In Commercial Distribution

  • 10889981042929 ()

  • 8mm
50-5008

  • Cannulated surgical drill bit, single-use
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
Occipital Screw, 6mm. 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
50-5006
In Commercial Distribution

  • 10889981042905 ()

  • 6mm
50-5006

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia 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
50-4550
Not in Commercial Distribution

  • 10889981042899 ()

  • 4.5 Dia X 50mm
50-4550

  • Cannulated surgical drill bit, single-use
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 Screw,4.5 Dia 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
50-4540
Not in Commercial Distribution

  • 10889981042875 ()

  • 4.5 Dia X 40mm
50-4540

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia 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
50-4538
Not in Commercial Distribution

  • 10889981042868 ()

  • 4.5 Dia X 38mm
50-4538

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia 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
50-4536
Not in Commercial Distribution

  • 10889981042851 ()

  • 4.5 Dia X 36mm
50-4536

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia 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
50-4534
Not in Commercial Distribution

  • 10889981042844 ()

  • 4.5 Dia X 34mm
50-4534

  • Cannulated surgical drill bit, single-use
Sierra Screw,4.5 Dia 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
50-4532
In Commercial Distribution

  • 10889981042837 ()

  • 4.5 Dia X 32mm
50-4532

  • Cannulated surgical drill bit, single-use
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 Screw,4.5 Dia 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
50-4528
In Commercial Distribution

  • 10889981042813 ()

  • 4.5 Dia X 28mm
50-4528

  • Cannulated surgical drill bit, single-use
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