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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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Cascadia™ Interbody System - 10888857369542

Trial, Size 12x14x8 mm, 7°
K2M, INC.
SP-2437-15
In Commercial Distribution

  • 10888857369542 ()

  • Width: 14 Millimeter
  • Angle: 7 degree
  • Height: 8 Millimeter
  • Length: 12 Millimeter
SP-2437-15

  • General internal orthopaedic fixation system implantation kit

BONE FILE #12 SINGLE CUT HD D/E - D928105212HD0

No Description
W.H. Holden, Inc.
10-5212HD
In Commercial Distribution

  • D928105212HD0 ()


  • Bone file/rasp, reciprocating, single-use

BONE FILE #10 - D9281052100

No Description
W.H. Holden, Inc.
10-5210
In Commercial Distribution

  • D9281052100 ()


  • Bone file/rasp, reciprocating, single-use

Cascadia™ Interbody System - 10888857369528

Trial, Size 12x14x6 mm, 7°
K2M, INC.
SP-2437-13
In Commercial Distribution

  • 10888857369528 ()

  • Length: 12 Millimeter
  • Angle: 7 degree
  • Width: 14 Millimeter
  • Height: 6 Millimeter
SP-2437-13

  • General internal orthopaedic fixation system implantation kit

Cascadia™ Interbody System - 10888857369511

Trial, Size 12x14x5 mm, 7°
K2M, INC.
SP-2437-12
In Commercial Distribution

  • 10888857369511 ()

  • Length: 12 Millimeter
  • Width: 14 Millimeter
  • Angle: 7 degree
  • Height: 5 Millimeter
SP-2437-12

  • General internal orthopaedic fixation system implantation kit

Cascadia™ Interbody System - 10888857369504

Trial, Size 12x14x15 mm, 0°
K2M, INC.
SP-2437-11
In Commercial Distribution

  • 10888857369504 ()

  • Length: 12 Millimeter
  • Height: 15 Millimeter
  • Width: 14 Millimeter
SP-2437-11

  • General internal orthopaedic fixation system implantation kit

Cascadia™ Interbody System - 10888857369498

Trial, Size 12x14x14 mm, 0°
K2M, INC.
SP-2437-10
In Commercial Distribution

  • 10888857369498 ()

  • Width: 14 Millimeter
  • Height: 14 Millimeter
  • Length: 12 Millimeter
SP-2437-10

  • General internal orthopaedic fixation system implantation kit

SINUS INSTRUMENT #8 SM GRAFT 1.3 / 2.8mm HD D/E - D9281051998HD0

No Description
W.H. Holden, Inc.
10-5199-8HD
In Commercial Distribution

  • D9281051998HD0 ()


  • Dental osteotome set

Cascadia™ Interbody System - 10888857369474

Trial, Size 12x14xSize 12 mm, 0°
K2M, INC.
SP-2437-08
In Commercial Distribution

  • 10888857369474 ()

  • Length: 12 Millimeter
  • Height: 12 Millimeter
  • Width: 14 Millimeter
SP-2437-08

  • General internal orthopaedic fixation system implantation kit

Cascadia™ Interbody System - 10888857369467

Trial, Size 12x14x11 mm, 0°
K2M, INC.
SP-2437-07
In Commercial Distribution

  • 10888857369467 ()

  • Height: 11 Millimeter
  • Length: 12 Millimeter
  • Width: 14 Millimeter
SP-2437-07

  • General internal orthopaedic fixation system implantation kit

SINUS INSTRUMENT #10 LARGE GRAFT PACKER, 4-5mm HF D/E - D92810519910HF0

No Description
W.H. Holden, Inc.
10-5199-10HF
In Commercial Distribution

  • D92810519910HF0 ()


  • Dental osteotome set

Cascadia™ Interbody System - 10888857369443

Trial, Size 12x14x9 mm, 0°
K2M, INC.
SP-2437-05
In Commercial Distribution

  • 10888857369443 ()

  • Length: 12 Millimeter
  • Height: 9 Millimeter
  • Width: 14 Millimeter
SP-2437-05

  • General internal orthopaedic fixation system implantation kit

BOSACK PACKER 4mm-6mm, HF HANDLE - D92810519910BHF0

No Description
W.H. Holden, Inc.
10-5199-10BHF
In Commercial Distribution

  • D92810519910BHF0 ()


  • Dental osteotome set

BOSACK PACKER 4mm-6mm HD - D92810519910BHD0

No Description
W.H. Holden, Inc.
10-5199-10BHD
In Commercial Distribution

  • D92810519910BHD0 ()


  • Dental osteotome set

Cascadia™ Interbody System - 10888857369412

Trial, Size 12x14x6 mm, 0°
K2M, INC.
SP-2437-02
In Commercial Distribution

  • 10888857369412 ()

  • Height: 6 Millimeter
  • Length: 12 Millimeter
  • Width: 14 Millimeter
SP-2437-02

  • General internal orthopaedic fixation system implantation kit

BONE CHISEL BONE EXPANSION INSTR 8mm - D9281051980

No Description
W.H. Holden, Inc.
10-5198
In Commercial Distribution

  • D9281051980 ()


  • Dental osteotome set

OZARK Cervical Plate System - 10888857369290

Temporary Fixation Pin Holder
K2M, INC.
8801-90007
In Commercial Distribution

  • 10888857369290 ()
8801-90007

  • Orthopaedic bone pin container

BONE CHISEL BONE EXPANSION INSTR 6mm - D9281051960

No Description
W.H. Holden, Inc.
10-5196
In Commercial Distribution

  • D9281051960 ()


  • Dental osteotome set

ADJUSTABLE STOP 5.5mm - D928105195550

No Description
W.H. Holden, Inc.
10-5195-55
In Commercial Distribution

  • D928105195550 ()


  • Dental osteotome

OZARK Cervical Plate System - 10888857369238

Fixed Drill Guide
K2M, INC.
8801-90000
In Commercial Distribution

  • 10888857369238 ()
8801-90000

  • Surgical drill guide, reusable
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