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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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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 4, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-180-BL4S-S
In Commercial Distribution

  • 00889795137357 ()
P11-180-BL4S-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 (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
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
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
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-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, Nominal, CoCr
Paragon 28, Inc.
AOPSTSXXXXN
In Commercial Distribution

  • 00889795137203 ()
AOPSTSXXXXN

  • Coated ankle talus prosthesis
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
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
Removal Hook, Body
Paragon 28, Inc.
P36-970-0006
In Commercial Distribution

  • 00889795137111 ()
P36-970-0006

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

  • 00889795136961 ()
P36-912-2015

  • Orthopaedic guidewire, 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
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
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
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