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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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NILE™ Proximal Fixation System - 10888857291287

Medial Offset Connector
K2M, INC.
5401-75510
In Commercial Distribution

  • 10888857291287 ()

  • Length: 10 Millimeter
  • Outer Diameter: 6 Millimeter
  • Outer Diameter: 5.5 Millimeter
5401-75510

  • Cannulated surgical drill bit, single-use

NILE™ Proximal Fixation System - 10888857291270

Semi-Adj Transverse Connector Single Slot, Size 28 mm
K2M, INC.
5401-70028A
In Commercial Distribution

  • 10888857291270 ()

  • Length: 28 Millimeter
  • Outer Diameter: 6 Millimeter
  • Outer Diameter: 5.5 Millimeter
5401-70028A

  • Cannulated surgical drill bit, single-use

NILE™ Proximal Fixation System - 10888857291263

Semi-Adj Transverse Connector Dual Slot, Size 34 mm
K2M, INC.
5401-70034A
In Commercial Distribution

  • 10888857291263 ()

  • Outer Diameter: 6 Millimeter
  • Length: 34 Millimeter
  • Outer Diameter: 5.5 Millimeter
5401-70034A

  • Cannulated surgical drill bit, single-use

NILE™ Proximal Fixation System - 10888857291256

Semi-Adj Transverse Connector Dual Slot, Size 40 mm
K2M, INC.
5401-70040A
In Commercial Distribution

  • 10888857291256 ()

  • Outer Diameter: 6 Millimeter
  • Length: 40 Millimeter
  • Outer Diameter: 5.5 Millimeter
5401-70040A

  • Cannulated surgical drill bit, single-use

NILE™ Proximal Fixation System - 10888857291249

Semi-Adj Transverse Connector Single Slot, Size 31 mm
K2M, INC.
5401-70031A
In Commercial Distribution

  • 10888857291249 ()

  • Length: 31 Millimeter
  • Outer Diameter: 5.5 Millimeter
  • Outer Diameter: 6 Millimeter
5401-70031A

  • Cannulated surgical drill bit, single-use

NILE™ Proximal Fixation System - 10888857291232

Semi-Adj Transverse Connector Dual Slot, Size 37 mm
K2M, INC.
5401-70037A
In Commercial Distribution

  • 10888857291232 ()

  • Length: 37 Millimeter
  • Outer Diameter: 6 Millimeter
  • Outer Diameter: 5.5 Millimeter
5401-70037A

  • Cannulated surgical drill bit, single-use

NILE™ Proximal Fixation System - 10888857291225

Semi-Adj Transverse Connector Dual Slot, Size 43 mm
K2M, INC.
5401-70043A
In Commercial Distribution

  • 10888857291225 ()

  • Length: 43 Millimeter
  • Outer Diameter: 5.5 Millimeter
  • Outer Diameter: 6 Millimeter
5401-70043A

  • Cannulated surgical drill bit, single-use

NILE™ Proximal Fixation System - 10888857291195

Transverse Connector, Adjustable, Size 45 mm - 48 mm
K2M, INC.
5401-74548
In Commercial Distribution

  • 10888857291195 ()

  • Length: 45 Millimeter
  • Outer Diameter: 6 Millimeter
  • Outer Diameter: 5.5 Millimeter
5401-74548

  • Cannulated surgical drill bit, single-use

NILE™ Proximal Fixation System - 10888857291188

Transverse Connector, Adjustable, Size 50 mm - 58 mm
K2M, INC.
5401-75058
In Commercial Distribution

  • 10888857291188 ()

  • Outer Diameter: 6 Millimeter
  • Length: 50 Millimeter
  • Outer Diameter: 5.5 Millimeter
5401-75058

  • Cannulated surgical drill bit, single-use

NILE™ Proximal Fixation System - 10888857291171

Transverse Connector, Adjustable, Size 47 mm - 52 mm
K2M, INC.
5401-74752
In Commercial Distribution

  • 10888857291171 ()

  • Length: 47 Millimeter
  • Outer Diameter: 5.5 Millimeter
  • Outer Diameter: 6 Millimeter
5401-74752

  • Cannulated surgical drill bit, single-use

EVEREST Spinal System - 10888857290662

Provisional Split Driver Size 30 Small Handle
K2M, INC.
5101-90193
In Commercial Distribution

  • 10888857290662 ()
5101-90193

  • Orthopaedic implant driver

EVEREST Spinal System - 10888857283428

Driver Sleeve
K2M, INC.
5101-90186
In Commercial Distribution

  • 10888857283428 ()
5101-90186

  • Orthopaedic prosthesis implantation positioning instrument, reusable

EVEREST Spinal System - 10888857279421

Rod Pusher XT
K2M, INC.
5101-90177
In Commercial Distribution

  • 10888857279421 ()
5101-90177

  • Orthopaedic implant driver

CAPRI™ Corpectomy Cage System - 10888857279209

Lordosis/Kyphosis Driver Inner Shaft, Size Inner Shaft
K2M, INC.
2112-90053
In Commercial Distribution

  • 10888857279209 ()
2112-90053

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CAPRI™ Corpectomy Cage System - 10888857279148

Lordosis/Kyphosis Driver Outer Shaft, Size Outer Shaft
K2M, INC.
2112-90052
In Commercial Distribution

  • 10888857279148 ()
2112-90052

  • Orthopaedic prosthesis implantation positioning instrument, reusable

ORTHOSOURCE - D91120130

Single Tooth Movement Screw Driver
ORTHOSOURCE
2013
In Commercial Distribution

  • D91120130 ()


  • Orthodontic palate expander/teeth aligner, self-removable

NILE Alternative Fixation System - 10888857273191

Driver Shaft Size 20
K2M, INC.
5401-90030
In Commercial Distribution

  • 10888857273191 ()
5401-90030

  • Orthopaedic prosthesis implantation positioning instrument, reusable

UNIGRIP DRIVER - D928837024UGD0

No Description
W.H. Holden, Inc.
83-7024-UGD
In Commercial Distribution

  • D928837024UGD0 ()


  • Surgical screwdriver, reusable

SCS DRIVER - D928837024SCS0

No Description
W.H. Holden, Inc.
83-7024-SCS
In Commercial Distribution

  • D928837024SCS0 ()


  • Surgical screwdriver, reusable

.050" HEX DRIVER - D9288370240500

No Description
W.H. Holden, Inc.
83-7024-050
In Commercial Distribution

  • D9288370240500 ()


  • Surgical screwdriver, reusable

1.2MM/.048" HEX - D9288370240

No Description
W.H. Holden, Inc.
83-7024
In Commercial Distribution

  • D9288370240 ()


  • Surgical screwdriver, reusable

BRACKET PLACING INSTR SPINA - D9288370230

No Description
W.H. Holden, Inc.
83-7023
In Commercial Distribution

  • D9288370230 ()


  • Surgical screwdriver, reusable

BEHR AUTO HAMMER - D9282010100

No Description
W.H. Holden, Inc.
20-1010
In Commercial Distribution

  • D9282010100 ()


  • Surgical mallet

PARTSCH MALLET-S/S HF - D928201002HF0

No Description
W.H. Holden, Inc.
20-1002HF
In Commercial Distribution

  • D928201002HF0 ()


  • Surgical mallet

REPLACEMENT S/S RINGS MEAD MALLET - D928201001210

No Description
W.H. Holden, Inc.
20-1001-2
In Commercial Distribution

  • D928201001210 ()


  • Surgical mallet

REPLACEMENT DELRIN FACE HUFRIEDY - D9282010011H0

No Description
W.H. Holden, Inc.
20-1001-1H
In Commercial Distribution

  • D9282010011H0 ()


  • Surgical mallet

REPLACEMENT DELRIN FACE MEAD MALLET - D92820100110

No Description
W.H. Holden, Inc.
20-1001-1
In Commercial Distribution

  • D92820100110 ()


  • Surgical mallet

REPLACEMENT DELRIN FACE SM. ROUND - D928201000S20

No Description
W.H. Holden, Inc.
20-1000S-2
In Commercial Distribution

  • D928201000S20 ()


  • Surgical mallet

K MALLET - D928201000K0

No Description
W.H. Holden, Inc.
20-1000K
In Commercial Distribution

  • D928201000K0 ()


  • Surgical mallet

REPLACEMENT MALLET FACE DELRIN HU-FR - D9282010001H0

No Description
W.H. Holden, Inc.
20-1000-1H
In Commercial Distribution

  • D9282010001H0 ()


  • Surgical mallet

MALLET S/STEEL W/DELRIN FACES - D9282010000

No Description
W.H. Holden, Inc.
20-1000
In Commercial Distribution

  • D9282010000 ()


  • Surgical mallet

MANUAL HANDPIECE DRIVER, FITS LATCH CONNECT 1:1 RATIO - D928200008C0

No Description
W.H. Holden, Inc.
20-0008C
In Commercial Distribution

  • D928200008C0 ()


  • Manual surgical rotary handpiece, reusable

MANUAL HANDPIECE DRIVER, FITS LATCH CONNECT 1:1 RATIO - D9282000080

No Description
W.H. Holden, Inc.
20-0008
In Commercial Distribution

  • D9282000080 ()


  • Manual surgical rotary handpiece, reusable

Axis Spine Technologies ALIF System Instrument - 05056619801083

ALIF Angled Screw Inserter
AXIS SPINE TECHNOLOGIES LTD
A6200525
In Commercial Distribution

  • 05056619801083 ()
A6200525

  • Surgical screwdriver, reusable

Axis Spine Technologies ALIF System Instrument - 05056619801076

Screwdriver XL
AXIS SPINE TECHNOLOGIES LTD
A6200375
In Commercial Distribution

  • 05056619801076 ()
A6200375

  • Surgical screwdriver, reusable

Axis Spine Technologies ALIF System Instrument - 05056619801069

Screwdriver
AXIS SPINE TECHNOLOGIES LTD
A6200325
In Commercial Distribution

  • 05056619801069 ()
A6200325

  • Surgical screwdriver, reusable

Axis Spine Technologies ALIF System Instrument - 05056619801038

Slotted Mallet
AXIS SPINE TECHNOLOGIES LTD
A6201950
In Commercial Distribution

  • 05056619801038 ()
A6201950

  • Surgical mallet

CAYMAN Plate System - 10888857247734

Capture Driver, Sleeve
K2M, INC.
SP-1344-02
In Commercial Distribution

  • 10888857247734 ()
SP-1344-02

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CHESAPEAKE Stabilization System - 10888857247659

Universal Driver Size Tapered, Size 20
K2M, INC.
SP-1282
In Commercial Distribution

  • 10888857247659 ()
SP-1282

  • Surgical screwdriver, reusable

PYRENEES Cervical Plate System - 10888857247314

Retaining Driver Size 13
K2M, INC.
6712-90000
In Commercial Distribution

  • 10888857247314 ()
6712-90000

  • Orthopaedic prosthesis implantation positioning instrument, reusable

SANTORINI™ Corpectomy Cage System - 10888857243187

Non-Tapered Driver, Size 15
K2M, INC.
K2-17-2024-01
In Commercial Distribution

  • 10888857243187 ()
K2-17-2024-01

  • Orthopaedic implant driver

CASPIAN Spinal System - 10888857242586

Reduction Jack Rotation Tube, w/Driver
K2M, INC.
K2-11-2213-01
In Commercial Distribution

  • 10888857242586 ()
K2-11-2213-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CASPIAN Spinal System - 10888857242234

Tapered Double Ended Driver Size 15
K2M, INC.
K2-11-2047-01
In Commercial Distribution

  • 10888857242234 ()
K2-11-2047-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CASPIAN Spinal System - 10888857242227

Torque Limiting Driver Size 15
K2M, INC.
K2-11-2042-01
In Commercial Distribution

  • 10888857242227 ()
K2-11-2042-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable

PYRENEES® Cervical Plate System - 10888857261761

Drill, Size Dia. 2.3x16 mm
K2M, INC.
6808-90028
In Commercial Distribution

  • 10888857261761 ()
6808-90028

  • Cannulated surgical drill bit, single-use

PYRENEES® Cervical Plate System - 10888857261754

Drill, Size Dia. 2.3x14 mm
K2M, INC.
6808-90027
In Commercial Distribution

  • 10888857261754 ()
6808-90027

  • Cannulated surgical drill bit, single-use

PYRENEES® Cervical Plate System - 10888857261747

Drill, Size Dia. 2.3x12 mm
K2M, INC.
6808-90026
In Commercial Distribution

  • 10888857261747 ()
6808-90026

  • Cannulated surgical drill bit, single-use

PYRENEES® Cervical Plate System - 10888857261730

Drill, Size Dia. 2.3x10 mm
K2M, INC.
6808-90025
In Commercial Distribution

  • 10888857261730 ()
6808-90025

  • Cannulated surgical drill bit, single-use

PYRENEES® Cervical Plate System - 10888857261686

Single Barrel Drill, Size Dia. 2.3x16 mm
K2M, INC.
6808-90022
In Commercial Distribution

  • 10888857261686 ()
6808-90022

  • Cannulated surgical drill bit, single-use

PYRENEES® Cervical Plate System - 10888857261679

Single Barrel Drill, Size Dia. 2.3x14 mm
K2M, INC.
6808-90021
In Commercial Distribution

  • 10888857261679 ()
6808-90021

  • Cannulated surgical drill bit, single-use
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