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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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APEX 3D S Total Ankle Replacement System - 00889795137418

Short Stem Tibia, ARC, Short Stem (12X12MM Lattice), Left, Size 6, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-180-BL6S-S
In Commercial Distribution

  • 00889795137418 ()
P11-180-BL6S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137395

Short Stem Tibia, ARC, Short Stem (12X12MM Lattice), Left, Size 5, Long, 3DP - Sterile
Paragon 28, Inc.
P11-180-BL5L-S
In Commercial Distribution

  • 00889795137395 ()
P11-180-BL5L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137388

Short Stem Tibia, ARC, Short Stem (12X12MM Lattice), Left, Size 5, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-180-BL5S-S
In Commercial Distribution

  • 00889795137388 ()
P11-180-BL5S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137364

Short Stem Tibia, ARC, Short Stem (12X10.5MM Lattice), Left, Size 4, Long, 3DP - Sterile
Paragon 28, Inc.
P11-180-BL4L-S
In Commercial Distribution

  • 00889795137364 ()
P11-180-BL4L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137357

Short Stem Tibia, ARC, Short Stem (12X10.5MM Lattice), Left, Size 4, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-180-BL4S-S
In Commercial Distribution

  • 00889795137357 ()
P11-180-BL4S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137333

Short Stem Tibia, ARC, Short Stem (12X10.5MM Lattice), Left, Size 3, Long, 3DP - Sterile
Paragon 28, Inc.
P11-180-BL3L-S
In Commercial Distribution

  • 00889795137333 ()
P11-180-BL3L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137326

Short Stem Tibia, ARC, Short Stem (12X10.5MM Lattice), Left, Size 3, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-180-BL3S-S
In Commercial Distribution

  • 00889795137326 ()
P11-180-BL3S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137302

Short Stem Tibia, ARC, Short Stem (12X9MM Lattice), Left, Size 2, Long, 3DP - Sterile
Paragon 28, Inc.
P11-180-BL2L-S
In Commercial Distribution

  • 00889795137302 ()
P11-180-BL2L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137296

Short Stem Tibia, ARC, Short Stem (12X9MM Lattice), Left, Size 2, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-180-BL2S-S
In Commercial Distribution

  • 00889795137296 ()
P11-180-BL2S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137265

Short Stem Tibia, ARC, Short Stem (12X9MM Lattice), Left, Size 1, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-180-BL1S-S
In Commercial Distribution

  • 00889795137265 ()
P11-180-BL1S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795137241

APEX 3D-PS Total Ankle Replacement System, Case Short Base
Paragon 28, Inc.
P10-900-CSSB
In Commercial Distribution

  • 00889795137241 ()
P10-900-CSSB

  • Device sterilization/disinfection container, reusable

Patient Specific Talus Spacer - 00889795137203

Patient Specific Talus Spacer, Nominal, CoCr
Paragon 28, Inc.
AOPSTSXXXXN
In Commercial Distribution

  • 00889795137203 ()
AOPSTSXXXXN

  • Coated ankle talus prosthesis

Phantom® Fibula Nail System - 00889795137180

1.6mm x 70mm, Sterilization K-Wire Container
Paragon 28, Inc.
P36-913-1670
In Commercial Distribution

  • 00889795137180 ()
P36-913-1670

  • Device sterilization/disinfection container, reusable

Phantom® Fibula Nail System - 00889795137135

2.0mm x 150mm, Sterilization K-Wire Container
Paragon 28, Inc.
P36-913-2015
In Commercial Distribution

  • 00889795137135 ()
P36-913-2015

  • Device sterilization/disinfection container, reusable

Phantom® Fibula Nail System - 00889795137111

Removal Hook, Body
Paragon 28, Inc.
P36-970-0006
In Commercial Distribution

  • 00889795137111 ()
P36-970-0006

  • Bone hook

Phantom® Fibula Nail System - 00889795137098

Screw Countersink, AO Quick Connect
Paragon 28, Inc.
P36-911-2735
In Commercial Distribution

  • 00889795137098 ()
P36-911-2735

  • Surgical countersink, single-use

Phantom® Fibula Nail System - 00889795137074

3.2mm R3ACT Drill Bit, 14mm Calibrated, AO Quick Connect
Paragon 28, Inc.
P36-910-3214
In Commercial Distribution

  • 00889795137074 ()
P36-910-3214

  • Fluted surgical drill bit, single-use

Phantom® Fibula Nail System - 00889795137050

6.5mm Proximal Reamer, Solid, AO Quick Connect
Paragon 28, Inc.
P36-915-6531
In Commercial Distribution

  • 00889795137050 ()
P36-915-6531

  • Bone-resection orthopaedic reamer, single-use

Phantom® Fibula Nail System - 00889795137043

6.0mm Proximal Reamer, Solid, AO Quick Connect
Paragon 28, Inc.
P36-915-6031
In Commercial Distribution

  • 00889795137043 ()
P36-915-6031

  • Bone-resection orthopaedic reamer, single-use

Phantom® Fibula Nail System - 00889795137036

5.2mm Proximal Reamer, Solid, AO Quick Connect
Paragon 28, Inc.
P36-915-5231
In Commercial Distribution

  • 00889795137036 ()
P36-915-5231

  • Bone-resection orthopaedic reamer, single-use

Phantom® Fibula Nail System - 00889795137029

4.5mm Proximal Reamer, Solid, AO Quick Connect
Paragon 28, Inc.
P36-915-4531
In Commercial Distribution

  • 00889795137029 ()
P36-915-4531

  • Bone-resection orthopaedic reamer, single-use

Phantom® Fibula Nail System - 00889795137012

3.9mm Proximal Reamer, Solid, AO Quick Connect
Paragon 28, Inc.
P36-915-3931
In Commercial Distribution

  • 00889795137012 ()
P36-915-3931

  • Bone-resection orthopaedic reamer, single-use

Phantom® Fibula Nail System - 00889795137005

3.3mm Proximal Reamer, Solid, AO Quick Connect
Paragon 28, Inc.
P36-915-3331
In Commercial Distribution

  • 00889795137005 ()
P36-915-3331

  • Bone-resection orthopaedic reamer, single-use

Phantom® Fibula Nail System - 00889795136992

2.6mm Proximal Reamer, Solid, AO Quick Connect
Paragon 28, Inc.
P36-915-2632
In Commercial Distribution

  • 00889795136992 ()
P36-915-2632

  • Bone-resection orthopaedic reamer, single-use

Phantom® Fibula Nail System - 00889795136961

2.0mm x 150mm, Trocar K-Wire
Paragon 28, Inc.
P36-912-2015
In Commercial Distribution

  • 00889795136961 ()
P36-912-2015

  • Orthopaedic guidewire, single-use

Phantom® Fibula Nail System - 00889795136954

1.6mm x 230mm, Entry Guidewire, Trocar
Paragon 28, Inc.
P36-912-1623
In Commercial Distribution

  • 00889795136954 ()
P36-912-1623

  • Orthopaedic guidewire, single-use

APEX 3D S Total Ankle Replacement System - 00889795136930

Short Stem Tibia, Instrument, Tibial Docking Fixture, Sizes 1-2
Paragon 28, Inc.
P11-810-TB12
In Commercial Distribution

  • 00889795136930 ()
P11-810-TB12

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795136923

Short Stem Tibia, Instrument, Drill Bit, Pilot, D9 x H7.5
Paragon 28, Inc.
P11-854-D09S
In Commercial Distribution

  • 00889795136923 ()
P11-854-D09S

  • Cannulated surgical drill bit, single-use

APEX 3D S Total Ankle Replacement System - 00889795136893

Short Stem Tibia, Instrument, Drill Bit Cap D12, Tall
Paragon 28, Inc.
P11-854-C12T
In Commercial Distribution

  • 00889795136893 ()
P11-854-C12T

  • Cannulated surgical drill bit, single-use

APEX 3D S Total Ankle Replacement System - 00889795136879

Short Stem Tibia, Instrument, Drill Bit Cap D10.5, Tall
Paragon 28, Inc.
P11-854-C10T
In Commercial Distribution

  • 00889795136879 ()
P11-854-C10T

  • Cannulated surgical drill bit, single-use

APEX 3D S Total Ankle Replacement System - 00889795136824

Short Stem Tibia, Instrument, Drill Bit Cap D9, Tall
Paragon 28, Inc.
P11-854-C09T
In Commercial Distribution

  • 00889795136824 ()
P11-854-C09T

  • Cannulated surgical drill bit, single-use

Special Instrument - 00889795151780

Special Instrument, Straight Nail Short Dual Calc Screw Guide Assembly
Paragon 28, Inc.
SP31-950-0007
In Commercial Distribution

  • 00889795151780 ()
SP31-950-0007

  • Surgical drill guide, reusable

Special Instrument - 00889795151773

Special Instrument, Straight Nail Short Calc Screw K-wire Guide
Paragon 28, Inc.
SP31-950-0006
In Commercial Distribution

  • 00889795151773 ()
SP31-950-0006

  • Surgical drill guide, reusable

Special Instrument - 00889795151766

Special Instrument, Straight Nail Short Calc Screw Drill Guide
Paragon 28, Inc.
SP31-950-0004
In Commercial Distribution

  • 00889795151766 ()
SP31-950-0004

  • Surgical drill guide, reusable

Specialty Instrument - 00889795150059

Special Instrument, Precision MIS Drill/K-wire Guide, 4.0 Screw
Paragon 28, Inc.
SP27-943-0040
In Commercial Distribution

  • 00889795150059 ()
SP27-943-0040

  • Surgical drill guide, reusable

Specialty Instrument - 00889795150042

Special Instrument, Precision MIS Drill/K-wire Guide, 3.5 Screw
Paragon 28, Inc.
SP27-943-0035
In Commercial Distribution

  • 00889795150042 ()
SP27-943-0035

  • Surgical drill guide, reusable

Specialty Instrument - 00889795150035

Special Instrument, Precision MIS Drill/K-wire Guide, 3.0 Screw
Paragon 28, Inc.
SP27-943-0030
In Commercial Distribution

  • 00889795150035 ()
SP27-943-0030

  • Surgical drill guide, reusable

Baby Gorilla® / Gorilla® Plating System - 00889795150011

Gorilla®, R3CON™ Screw, Ø2.7 x 74mm, Non-Locking, Solid, TiA
Paragon 28, Inc.
P50-453-2774
In Commercial Distribution

  • 00889795150011 ()
P50-453-2774

  • Orthopaedic bone screw (non-sliding)

Baby Gorilla® / Gorilla® Plating System - 00889795150004

Gorilla®, R3CON™ Screw, Ø2.7 x 72mm, Non-Locking, Solid, TiA
Paragon 28, Inc.
P50-453-2772
In Commercial Distribution

  • 00889795150004 ()
P50-453-2772

  • Orthopaedic bone screw (non-sliding)

Specialty Instrument - 00889795146625

MIS Chamfer Screw, 5mm Reduction Wire
Paragon 28, Inc.
SP27-182-0005
In Commercial Distribution

  • 00889795146625 ()
SP27-182-0005

  • Orthopaedic guidewire, single-use
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