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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Short Stem Tibia, ARC, Short Stem (12X9MM Lattice), Right, Size 1, Short, 3DP - Sterile
Paragon 28, Inc.
P11-180-BR10-S
In Commercial Distribution

  • 00889795137432 ()
P11-180-BR10-S

  • Fixed-bearing total ankle prosthesis
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
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
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
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
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
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-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
2.3mm x 230mm, Sterilization K-Wire Container
Paragon 28, Inc.
P36-913-2323
In Commercial Distribution

  • 00889795137159 ()
P36-913-2323

  • Device sterilization/disinfection container, reusable
1.6mm x 230mm, Sterilization K-Wire Container
Paragon 28, Inc.
P36-913-1623
In Commercial Distribution

  • 00889795137128 ()
P36-913-1623

  • Device sterilization/disinfection container, reusable
4.0mm Single Lead Tap, AO Quick Connect
Paragon 28, Inc.
P36-921-4018
In Commercial Distribution

  • 00889795137104 ()
P36-921-4018

  • Bone tap, single-use
Screw Countersink, AO Quick Connect
Paragon 28, Inc.
P36-911-2735
In Commercial Distribution

  • 00889795137098 ()
P36-911-2735

  • Surgical countersink, single-use
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
2.5mm Drill Bit, Calibrated, AO Quick Connect
Paragon 28, Inc.
P36-910-2519
In Commercial Distribution

  • 00889795137067 ()
P36-910-2519

  • Fluted surgical drill bit, single-use
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
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
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
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
1.6mm x 230mm, Entry Guidewire, Trocar
Paragon 28, Inc.
P36-912-1623
In Commercial Distribution

  • 00889795136954 ()
P36-912-1623

  • Orthopaedic guidewire, single-use
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
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
2.4 Threaded Shoulder Pin - Short Shank - 50mm Thread Length
Paragon 28, Inc.
P10-912-2450
In Commercial Distribution

  • 00889795136909 ()
P10-912-2450

  • Orthopaedic guidewire, single-use
Short Stem Tibia, Instrument, Drill Bit Cap D12, Short
Paragon 28, Inc.
P11-854-C12S
In Commercial Distribution

  • 00889795136886 ()
P11-854-C12S

  • Cannulated surgical drill bit, single-use
Short Stem Tibia, Instrument, Drill Bit Cap D10.5, Short
Paragon 28, Inc.
P11-854-C10S
In Commercial Distribution

  • 00889795136862 ()
P11-854-C10S

  • Cannulated surgical drill bit, single-use
Short Stem Tibia, Instrument, Drill Bit Cap D9, Short
Paragon 28, Inc.
P11-854-C09S
In Commercial Distribution

  • 00889795136817 ()
P11-854-C09S

  • Cannulated surgical drill bit, single-use
3.5 Hex Driver, Ball Nose, Short
Paragon 28, Inc.
P99-150-HB35-SHORT
In Commercial Distribution

  • 00889795136800 ()
P99-150-HB35-SHORT

  • Surgical screwdriver, reusable
3.5 Hex Driver, Ball Nose, Standard
Paragon 28, Inc.
P99-150-HB35
In Commercial Distribution

  • 00889795136794 ()
P99-150-HB35

  • Surgical screwdriver, reusable
Phantom Hindfoot Nail, Compression End Cap, Long
Paragon 28, Inc.
P31-111-0000-07
In Commercial Distribution

  • 00889795136558 ()
P31-111-0000-07

  • Bone nail end-cap
Phantom Hindfoot Nail, Compression End Cap, Short
Paragon 28, Inc.
P31-111-0000-03
In Commercial Distribution

  • 00889795136541 ()
P31-111-0000-03

  • Bone nail end-cap
Phantom Hindfoot Nail, Shouldered End Cap, Long
Paragon 28, Inc.
P31-102-0005
In Commercial Distribution

  • 00889795136534 ()
P31-102-0005

  • Bone nail end-cap
Phantom Hindfoot Nail, Shouldered End Cap, Short
Paragon 28, Inc.
P31-102-0001
In Commercial Distribution

  • 00889795136527 ()
P31-102-0001

  • Bone nail end-cap
Phantom Nail: Straight Tension Screw
Paragon 28, Inc.
P31-100-0000-05
In Commercial Distribution

  • 00889795136510 ()
P31-100-0000-05

  • Orthopaedic bone screw (non-sliding)
Phantom Nail, Crossing Screw, Ø5.0mm x 90mm length, Headless
Paragon 28, Inc.
P32-350-090F
In Commercial Distribution

  • 00889795136503 ()
P32-350-090F

  • Orthopaedic bone screw (non-sliding)
Phantom Nail, Crossing Screw, Ø5.0mm x 85mm length, Headless
Paragon 28, Inc.
P32-350-085F
In Commercial Distribution

  • 00889795136497 ()
P32-350-085F

  • Orthopaedic bone screw (non-sliding)
Phantom Nail, Crossing Screw, Ø5.0mm x 80mm length, Headless
Paragon 28, Inc.
P32-350-080F
In Commercial Distribution

  • 00889795136480 ()
P32-350-080F

  • Orthopaedic bone screw (non-sliding)
Phantom Nail, Crossing Screw, Ø5.0mm x 75mm length, Headless
Paragon 28, Inc.
P32-350-075F
In Commercial Distribution

  • 00889795136473 ()
P32-350-075F

  • Orthopaedic bone screw (non-sliding)
Phantom Nail, Crossing Screw, Ø5.0mm x 70mm length, Headless
Paragon 28, Inc.
P32-350-070F
In Commercial Distribution

  • 00889795136466 ()
P32-350-070F

  • Orthopaedic bone screw (non-sliding)
Phantom Nail, Crossing Screw, Ø5.0mm x 65mm length, Headless
Paragon 28, Inc.
P32-350-065F
In Commercial Distribution

  • 00889795136459 ()
P32-350-065F

  • Orthopaedic bone screw (non-sliding)
Phantom Nail, Crossing Screw, Ø5.0mm x 60mm length, Headed
Paragon 28, Inc.
P32-450-060F
In Commercial Distribution

  • 00889795136442 ()
P32-450-060F

  • Orthopaedic bone screw (non-sliding)
Phantom Nail, Crossing Screw, Ø5.0mm x 58mm length, Headed
Paragon 28, Inc.
P32-450-058F
In Commercial Distribution

  • 00889795136435 ()
P32-450-058F

  • Orthopaedic bone screw (non-sliding)
Phantom Nail, Crossing Screw, Ø5.0mm x 56mm length, Headed
Paragon 28, Inc.
P32-450-056F
In Commercial Distribution

  • 00889795136428 ()
P32-450-056F

  • Orthopaedic bone screw (non-sliding)
Phantom Nail, Crossing Screw, Ø5.0mm x 54mm length, Headed
Paragon 28, Inc.
P32-450-054F
In Commercial Distribution

  • 00889795136411 ()
P32-450-054F

  • Orthopaedic bone screw (non-sliding)
Phantom Nail, Crossing Screw, Ø5.0mm x 38mm length, Headed
Paragon 28, Inc.
P32-450-038F
In Commercial Distribution

  • 00889795136404 ()
P32-450-038F

  • Orthopaedic bone screw (non-sliding)
Phantom Nail, Crossing Screw, Ø5.0mm x 36mm length, Headed
Paragon 28, Inc.
P32-450-036F
In Commercial Distribution

  • 00889795136398 ()
P32-450-036F

  • Orthopaedic bone screw (non-sliding)
Phantom Nail, Crossing Screw, Ø5.0mm x 34mm length, Headed
Paragon 28, Inc.
P32-450-034F
In Commercial Distribution

  • 00889795136381 ()
P32-450-034F

  • Orthopaedic bone screw (non-sliding)
Phantom Nail, Crossing Screw, Ø5.0mm x 32mm length, Headed
Paragon 28, Inc.
P32-450-032F
In Commercial Distribution

  • 00889795136374 ()
P32-450-032F

  • Orthopaedic bone screw (non-sliding)
Phantom Nail, Crossing Screw, Ø5.0mm x 30mm length, Headed
Paragon 28, Inc.
P32-450-030F
In Commercial Distribution

  • 00889795136367 ()
P32-450-030F

  • Orthopaedic bone screw (non-sliding)
Phantom Nail, Crossing Screw, Ø5.0mm x 28mm length, Headed
Paragon 28, Inc.
P32-450-028F
In Commercial Distribution

  • 00889795136350 ()
P32-450-028F

  • Orthopaedic bone screw (non-sliding)
Phantom Nail, Crossing Screw, Ø5.0mm x 26mm length, Headed
Paragon 28, Inc.
P32-450-026F
In Commercial Distribution

  • 00889795136343 ()
P32-450-026F

  • Orthopaedic bone screw (non-sliding)
Phantom Nail, Crossing Screw, Ø5.0mm x 24mm length, Headed
Paragon 28, Inc.
P32-450-024F
In Commercial Distribution

  • 00889795136336 ()
P32-450-024F

  • Orthopaedic bone screw (non-sliding)
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