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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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Triple Twist - M68510524T1

Triple Twist 5.5mm PEEK Suture Anchor
PARCUS MEDICAL LLC
10524T
In Commercial Distribution

  • M68510524T1 ()
  • M68510524T0 ()

  • Outer Diameter: 5.5 Millimeter
10524T

  • Tendon/ligament bone anchor, non-bioabsorbable

Twist - M685105221

Twist 5.5mm PEEK Suture Anchor with Needles
PARCUS MEDICAL LLC
10522
In Commercial Distribution

  • M685105221 ()
  • M685105220 ()

  • Outer Diameter: 5.5 Millimeter
10522

  • Tendon/ligament bone anchor, non-bioabsorbable

Twist - M68510517T1

Twist 5.5mm PEEK Suture Anchor
PARCUS MEDICAL LLC
10517T
In Commercial Distribution

  • M68510517T1 ()
  • M68510517T0 ()

  • Outer Diameter: 5.5 Millimeter
10517T

  • Tendon/ligament bone anchor, non-bioabsorbable

Twist - M685105171

Twist 5.5mm PEEK Suture Anchor
PARCUS MEDICAL LLC
10517
In Commercial Distribution

  • M685105171 ()
  • M685105170 ()

  • Outer Diameter: 5.5 Millimeter
10517

  • Tendon/ligament bone anchor, non-bioabsorbable

V-LoX - M68510410T1

5.5mm V-LoX Titanium Suture Anchor with Needles
PARCUS MEDICAL LLC
10410T
In Commercial Distribution

  • M68510410T1 ()
  • M68510410T0 ()

  • Outer Diameter: 5.5 Millimeter
10410T

  • Tendon/ligament bone anchor, non-bioabsorbable

V-LoX - M68510356T1

5.5mm V-LoX Titanium Suture Anchor
PARCUS MEDICAL LLC
10356T
In Commercial Distribution

  • M68510356T1 ()
  • M68510356T0 ()

  • Outer Diameter: 5.5 Millimeter
10356T

  • Tendon/ligament bone anchor, non-bioabsorbable

V-LoX3 - M68510324T1

5.5mm V-LoX3 PEEK CF Suture Anchor
PARCUS MEDICAL LLC
10324T
In Commercial Distribution

  • M68510324T1 ()
  • M68510324T0 ()

  • Outer Diameter: 5.5 Millimeter
10324T

  • Tendon/ligament bone anchor, non-bioabsorbable

NA - M685103151

55 Knotless Push-In Suture Anchor
PARCUS MEDICAL LLC
10315
In Commercial Distribution

  • M685103151 ()
  • M685103150 ()

  • Outer Diameter: 5.5 Millimeter
10315

  • Tendon/ligament bone anchor, non-bioabsorbable

V-LoX3 - M68510284T1

5.5mm V-LoX3 Titanium Suture Anchor
PARCUS MEDICAL LLC
10284T
In Commercial Distribution

  • M68510284T1 ()
  • M68510284T0 ()

  • Outer Diameter: 5.5 Millimeter
10284T

  • Tendon/ligament bone anchor, non-bioabsorbable

V-LoX3 - M685102841

5.5mm V-LoX3 Titanium Suture Anchor
PARCUS MEDICAL LLC
10284
In Commercial Distribution

  • M685102841 ()
  • M685102840 ()

  • Outer Diameter: 5.5 Millimeter
10284

  • Tendon/ligament bone anchor, non-bioabsorbable

V-LoX - M685102631

5.5mm V-LoX PEEK CF Suture Anchor with Needles
PARCUS MEDICAL LLC
10263
In Commercial Distribution

  • M685102631 ()
  • M685102630 ()

  • Outer Diameter: 5.5 Millimeter
10263

  • Tendon/ligament bone anchor, non-bioabsorbable

V-LoX - M68510253T1

5.5mm V-LoX PEEK CF Suture Anchor
PARCUS MEDICAL LLC
10253T
In Commercial Distribution

  • M68510253T1 ()
  • M68510253T0 ()

  • Outer Diameter: 5.5 Millimeter
10253T

  • Tendon/ligament bone anchor, non-bioabsorbable

V-LoX - M685102531

5.5mm V-LoX PEEK CF Suture Anchor
PARCUS MEDICAL LLC
10253
In Commercial Distribution

  • M685102531 ()
  • M685102530 ()

  • Outer Diameter: 5.5 Millimeter
10253

  • Tendon/ligament bone anchor, non-bioabsorbable

Black Diamond Pedicle Screw System - B062100100000J

The Osseus Black Diamond Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to match more closely the patient's anatomy.
Osseus Fusion Systems, LLC
1001-0000
In Commercial Distribution

  • 71341402JV ()
  • B062100100000J ()

  • Length: 300 Millimeter
  • Length: 250 Millimeter
  • Length: 200 Millimeter
  • Length: 120 Millimeter
  • Length: 115 Millimeter
  • Length: 110 Millimeter
  • Length: 105 Millimeter
  • Length: 40 Millimeter
  • Length: 35 Millimeter
  • Length: 30 Millimeter
  • Outer Diameter: 8.5 Millimeter
  • Outer Diameter: 7.5 Millimeter
  • Outer Diameter: 6.5 Millimeter
  • Outer Diameter: 5.5 Millimeter
  • Outer Diameter: 4.5 Millimeter
  • Depth: 90 Millimeter
  • Depth: 70 Millimeter
  • Depth: 50 Millimeter
  • Depth: 35 Millimeter
  • Depth: 30 Millimeter
  • Length: 45 Millimeter
  • Length: 50 Millimeter
  • Length: 55 Millimeter
  • Length: 60 Millimeter
  • Length: 65 Millimeter
  • Length: 70 Millimeter
  • Length: 75 Millimeter
  • Length: 80 Millimeter
  • Length: 85 Millimeter
  • Length: 90 Millimeter
  • Length: 95 Millimeter
  • Length: 100 Millimeter
1001-0000 to 1010-9999

  • Bone-screw internal spinal fixation system, non-sterile

X90 Pedicle Screw System - M697N605555SDDL1

Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 55
Xtant Medical Holdings, Inc.
N605555SD-DL
In Commercial Distribution

  • M697N605555SDDL1 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 55 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

X90 Pedicle Screw System - M697N605555SD1

Assembly, X90, 5.5 x 55 Self-Drilling Screw
Xtant Medical Holdings, Inc.
N605555SD
In Commercial Distribution

  • M697N605555SD1 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 55 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

X90 Pedicle Screw System - M697N605550SDDL1

Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 50
Xtant Medical Holdings, Inc.
N605550SD-DL
In Commercial Distribution

  • M697N605550SDDL1 ()

  • Length: 50 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

X90 Pedicle Screw System - M697N605550SD1

Assembly, X90, 5.5 x 50 Self-Drilling Screw
Xtant Medical Holdings, Inc.
N605550SD
In Commercial Distribution

  • M697N605550SD1 ()

  • Length: 50 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

X90 Pedicle Screw System - M697N605545SDDL1

Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 45
Xtant Medical Holdings, Inc.
N605545SD-DL
In Commercial Distribution

  • M697N605545SDDL1 ()

  • Length: 45 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

X90 Pedicle Screw System - M697N605545SD1

Assembly, X90, 5.5 x 45 Self-Drilling Screw
Xtant Medical Holdings, Inc.
N605545SD
In Commercial Distribution

  • M697N605545SD1 ()

  • Length: 45 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

X90 Pedicle Screw System - M697N605540SDDL1

Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 40
Xtant Medical Holdings, Inc.
N605540SD-DL
In Commercial Distribution

  • M697N605540SDDL1 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 40 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

X90 Pedicle Screw System - M697N605540SD1

Assembly, X90, 5.5 x 40 Self-Drilling Screw
Xtant Medical Holdings, Inc.
N605540SD
In Commercial Distribution

  • M697N605540SD1 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 40 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

X90 Pedicle Screw System - M697N605535SDDL1

Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 35
Xtant Medical Holdings, Inc.
N605535SD-DL
In Commercial Distribution

  • M697N605535SDDL1 ()

  • Length: 35 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

X90 Pedicle Screw System - M697N605535SD1

Assembly, X90, 5.5 x 35 Self-Drilling Screw
Xtant Medical Holdings, Inc.
N605535SD
In Commercial Distribution

  • M697N605535SD1 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 35 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

X90 Pedicle Screw System - M697N605530SDDL1

Assembly, X90, DUAL LEAD, SELF-DRILLING SCREW 5.5 x 30
Xtant Medical Holdings, Inc.
N605530SD-DL
In Commercial Distribution

  • M697N605530SDDL1 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 30 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

X90 Pedicle Screw System - M697N605530SD1

Assembly, X90, 5.5 x 30 Self-Drilling Screw
Xtant Medical Holdings, Inc.
N605530SD
In Commercial Distribution

  • M697N605530SD1 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 30 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697N600011051

Continuous Radius Rod, 5.5mm DIA. X 160
Xtant Medical Holdings, Inc.
N60001105
In Commercial Distribution

  • M697N600011051 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 160 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697N600011041

Continuous Radius Rod, 5.5mm DIA. X 150
Xtant Medical Holdings, Inc.
N60001104
In Commercial Distribution

  • M697N600011041 ()

  • Length: 150 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697N600011031

Continuous Radius Rod, 5.5mm DIA. X 140
Xtant Medical Holdings, Inc.
N60001103
In Commercial Distribution

  • M697N600011031 ()

  • Length: 140 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697N600011021

Continuous Radius Rod, 5.5mm DIA. X 130
Xtant Medical Holdings, Inc.
N60001102
In Commercial Distribution

  • M697N600011021 ()

  • Length: 130 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697N600011011

Continuous Radius Rod, 5.5mm DIA. X 120
Xtant Medical Holdings, Inc.
N60001101
In Commercial Distribution

  • M697N600011011 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 120 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697N600011001

Continuous Radius Rod, 5.5mm DIA. X 110
Xtant Medical Holdings, Inc.
N60001100
In Commercial Distribution

  • M697N600011001 ()

  • Length: 110 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697N600010991

Continuous Radius Rod, 5.5mm DIA. X 95
Xtant Medical Holdings, Inc.
N60001099
In Commercial Distribution

  • M697N600010991 ()

  • Length: 95 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697N600010981

Continuous Radius Rod, 5.5mm DIA. X 90
Xtant Medical Holdings, Inc.
N60001098
In Commercial Distribution

  • M697N600010981 ()

  • Length: 90 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697N600010971

Continuous Radius Rod, 5.5mm DIA. X 85
Xtant Medical Holdings, Inc.
N60001097
In Commercial Distribution

  • M697N600010971 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 85 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697N600010961

Continuous Radius Rod, 5.5mm DIA. X 75
Xtant Medical Holdings, Inc.
N60001096
In Commercial Distribution

  • M697N600010961 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 75 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697N600010951

Continuous Radius Rod, 5.5mm DIA. X 65
Xtant Medical Holdings, Inc.
N60001095
In Commercial Distribution

  • M697N600010951 ()

  • Length: 65 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697N600010941

Continuous Radius Rod, 5.5mm DIA. X 55
Xtant Medical Holdings, Inc.
N60001094
In Commercial Distribution

  • M697N600010941 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 55 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697N600010931

Continuous Radius Rod, 5.5mm DIA. X 45
Xtant Medical Holdings, Inc.
N60001093
In Commercial Distribution

  • M697N600010931 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 45 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697N600010921

Continuous Radius Rod, 5.5mm DIA. X 40
Xtant Medical Holdings, Inc.
N60001092
In Commercial Distribution

  • M697N600010921 ()

  • Length: 40 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697N600010911

Continuous Radius Rod, 5.5mm DIA. X 35
Xtant Medical Holdings, Inc.
N60001091
In Commercial Distribution

  • M697N600010911 ()

  • Length: 35 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697N600010811

5.5mm Diameter x 95mm Rod
Xtant Medical Holdings, Inc.
N60001081
In Commercial Distribution

  • M697N600010811 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 95 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697N600010801

5.5mm Diameter x 90mm Rod
Xtant Medical Holdings, Inc.
N60001080
In Commercial Distribution

  • M697N600010801 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 90 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697N600010791

5.5mm Diameter x 85mm Rod
Xtant Medical Holdings, Inc.
N60001079
In Commercial Distribution

  • M697N600010791 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 85 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697N600010781

5.5mm Diameter x 75mm Rod
Xtant Medical Holdings, Inc.
N60001078
In Commercial Distribution

  • M697N600010781 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 75 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697N600010771

5.5mm Diameter x 65mm Rod
Xtant Medical Holdings, Inc.
N60001077
In Commercial Distribution

  • M697N600010771 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 65 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697N600010761

5.5mm Diameter x 55mm Rod
Xtant Medical Holdings, Inc.
N60001076
In Commercial Distribution

  • M697N600010761 ()

  • Length: 55 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697N600010751

5.5mm Diameter x 50mm Rod
Xtant Medical Holdings, Inc.
N60001075
In Commercial Distribution

  • M697N600010751 ()

  • Length: 50 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697N600010741

5.5mm Diameter x 45mm Rod
Xtant Medical Holdings, Inc.
N60001074
In Commercial Distribution

  • M697N600010741 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 45 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697N600010731

5.5mm Diameter x 35mm Rod
Xtant Medical Holdings, Inc.
N60001073
In Commercial Distribution

  • M697N600010731 ()

  • Length: 35 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
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