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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 - 00889795137531

Short Stem Tibia, ARC, Short Stem (12X10.5MM Lattice), Right, Size 4, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-180-BR4S-S
In Commercial Distribution

  • 00889795137531 ()
P11-180-BR4S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137500

Short Stem Tibia, ARC, Short Stem (12X10.5MM Lattice), Right, Size 3, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-180-BR3S-S
In Commercial Distribution

  • 00889795137500 ()
P11-180-BR3S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137487

Short Stem Tibia, ARC, Short Stem (12X9MM Lattice), Right, Size 2, Long, 3DP - Sterile
Paragon 28, Inc.
P11-180-BR2L-S
In Commercial Distribution

  • 00889795137487 ()
P11-180-BR2L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137470

Short Stem Tibia, ARC, Short Stem (12X9MM Lattice), Right, Size 2, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-180-BR2S-S
In Commercial Distribution

  • 00889795137470 ()
P11-180-BR2S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137449

Short Stem Tibia, ARC, Short Stem (12X9MM Lattice), Right, Size 1, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-180-BR1S-S
In Commercial Distribution

  • 00889795137449 ()
P11-180-BR1S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D S Total Ankle Replacement System - 00889795137425

Short Stem Tibia, ARC, Short Stem (12X12MM Lattice), Left, Size 6, Long, 3DP - Sterile
Paragon 28, Inc.
P11-180-BL6L-S
In Commercial Distribution

  • 00889795137425 ()
P11-180-BL6L-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 - 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 - 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 - 00889795137272

Short Stem Tibia, ARC, Short Stem (12X9MM Lattice), Left, Size 1, Long, 3DP - Sterile
Paragon 28, Inc.
P11-180-BL1L-S
In Commercial Distribution

  • 00889795137272 ()
P11-180-BL1L-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 S Total Ankle Replacement System - 00889795137258

Short Stem Tibia, ARC, Short Stem (12X9MM Lattice), Left, Size 1, Short, 3DP - Sterile
Paragon 28, Inc.
P11-180-BL10-S
In Commercial Distribution

  • 00889795137258 ()
P11-180-BL10-S

  • Fixed-bearing total ankle prosthesis

Phantom® Fibula Nail System - 00889795137234

Bone Hook, Large Handle
Paragon 28, Inc.
P99-150-1007
In Commercial Distribution

  • 00889795137234 ()
P99-150-1007

  • Bone hook

Patient Specific Talus Spacer - 00889795137210

Patient Specific Talus Spacer, Small, CoCr
Paragon 28, Inc.
AOPSTSXXXXS
In Commercial Distribution

  • 00889795137210 ()
AOPSTSXXXXS

  • Coated ankle talus prosthesis

Patient Specific Talus Spacer - 00889795137203

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

  • 00889795137203 ()
AOPSTSXXXXN

  • Coated ankle talus prosthesis

Patient Specific Talus Spacer - 00889795137197

Patient Specific Talus Spacer, Large, CoCr
Paragon 28, Inc.
AOPSTSXXXXL
In Commercial Distribution

  • 00889795137197 ()
AOPSTSXXXXL

  • 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 - 00889795137081

3.2mm R3ACT Drill Bit, 17mm Calibrated, AO Quick Connect
Paragon 28, Inc.
P36-910-3217
In Commercial Distribution

  • 00889795137081 ()
P36-910-3217

  • Fluted surgical drill bit, 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 - 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 - 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 - 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

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

Baby Gorilla®/Gorilla® Plating System - 00889795112194

Lateral Straddle Plate, TC, Long, Right, 20-Hole, TiA
Paragon 28, Inc.
P53-412-R102
In Commercial Distribution

  • 00889795112194 ()
P53-412-R102

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795112170

Anterior Straddle Plate, TT, Contoured, Long, Right, 14-Hole, TiA
Paragon 28, Inc.
P53-411-R102
In Commercial Distribution

  • 00889795112170 ()
P53-411-R102

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795112156

Anterior Straddle Plate Long, Flat, Right, 14-Hole TiA
Paragon 28, Inc.
P53-411-R202
In Commercial Distribution

  • 00889795112156 ()
P53-411-R202

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795112149

Anterior Straddle Plate Long, Flat, Left, 14-Hole TiA
Paragon 28, Inc.
P53-411-L202
In Commercial Distribution

  • 00889795112149 ()
P53-411-L202

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795111913

RIBBON RETRACTOR, 0.50' X 8"
Paragon 28, Inc.
P99-157-0850
In Commercial Distribution

  • 00889795111913 ()
P99-157-0850

  • Hand-held surgical retractor, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111906

Gorilla, R3CON, Non-Locking Screw, Compact Thread, Ø3.50 x 40mm
Paragon 28, Inc.
P50-853-3540
In Commercial Distribution

  • 00889795111906 ()
P50-853-3540

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795111883

Gorilla, R3CON, Non-Locking Screw, Compact Thread, Ø3.50 x 36mm
Paragon 28, Inc.
P50-853-3536
In Commercial Distribution

  • 00889795111883 ()
P50-853-3536

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795111869

Gorilla, R3CON, Non-Locking Screw, Compact Thread, Ø3.50 x 32mm
Paragon 28, Inc.
P50-853-3532
In Commercial Distribution

  • 00889795111869 ()
P50-853-3532

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795111845

Gorilla, R3CON, Non-Locking Screw, Compact Thread, Ø3.50 x 28mm
Paragon 28, Inc.
P50-853-3528
In Commercial Distribution

  • 00889795111845 ()
P50-853-3528

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795111821

Gorilla, R3CON, Non-Locking Screw, Compact Thread, Ø3.50 x 24mm
Paragon 28, Inc.
P50-853-3524
In Commercial Distribution

  • 00889795111821 ()
P50-853-3524

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795111814

Gorilla, R3CON, Non-Locking Screw, Compact Thread, Ø3.50 x 22mm
Paragon 28, Inc.
P50-853-3522
In Commercial Distribution

  • 00889795111814 ()
P50-853-3522

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795111807

Gorilla, R3CON, Non-Locking Screw, Compact Thread, Ø3.50 x 20mm
Paragon 28, Inc.
P50-853-3520
In Commercial Distribution

  • 00889795111807 ()
P50-853-3520

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795111791

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 40mm
Paragon 28, Inc.
P50-753-3540
In Commercial Distribution

  • 00889795111791 ()
P50-753-3540

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795111784

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 38mm
Paragon 28, Inc.
P50-753-3538
In Commercial Distribution

  • 00889795111784 ()
P50-753-3538

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795111777

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 36mm
Paragon 28, Inc.
P50-753-3536
In Commercial Distribution

  • 00889795111777 ()
P50-753-3536

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795111760

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 34mm
Paragon 28, Inc.
P50-753-3534
In Commercial Distribution

  • 00889795111760 ()
P50-753-3534

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795111753

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 32mm
Paragon 28, Inc.
P50-753-3532
In Commercial Distribution

  • 00889795111753 ()
P50-753-3532

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795111746

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 30mm
Paragon 28, Inc.
P50-753-3530
In Commercial Distribution

  • 00889795111746 ()
P50-753-3530

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795111739

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 28mm
Paragon 28, Inc.
P50-753-3528
In Commercial Distribution

  • 00889795111739 ()
P50-753-3528

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795111722

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 26mm
Paragon 28, Inc.
P50-753-3526
In Commercial Distribution

  • 00889795111722 ()
P50-753-3526

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795111715

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 24mm
Paragon 28, Inc.
P50-753-3524
In Commercial Distribution

  • 00889795111715 ()
P50-753-3524

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795111708

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 22mm
Paragon 28, Inc.
P50-753-3522
In Commercial Distribution

  • 00889795111708 ()
P50-753-3522

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795111692

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 20mm
Paragon 28, Inc.
P50-753-3520
In Commercial Distribution

  • 00889795111692 ()
P50-753-3520

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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