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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-PS Total Ankle Replacement System, Talar Chamfer Resection Router, Ø9mm
Paragon 28, Inc.
P10-944-0975
In Commercial Distribution

  • 00889795063403 ()
P10-944-0975

  • Bone-resection orthopaedic reamer, reusable
Tibial Sizing Resection Block, Size 5
Paragon 28, Inc.
P10-942-SZ05
In Commercial Distribution

  • 00889795063380 ()
P10-942-SZ05

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Sizing Resection Block, Size 4
Paragon 28, Inc.
P10-942-SZ04
In Commercial Distribution

  • 00889795063373 ()
P10-942-SZ04

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Sizing Resection Block, Size 1
Paragon 28, Inc.
P10-942-SZ01
In Commercial Distribution

  • 00889795063342 ()
P10-942-SZ01

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Arc/Flat, Resection Block Size 6
Paragon 28, Inc.
P10-942-RS16
In Commercial Distribution

  • 00889795063335 ()
P10-942-RS16

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Arc/Flat, Resection Block Size 4
Paragon 28, Inc.
P10-942-RS14
In Commercial Distribution

  • 00889795063311 ()
P10-942-RS14

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Arc/Flat, Resection Block Size 1
Paragon 28, Inc.
P10-942-RS11
In Commercial Distribution

  • 00889795063281 ()
P10-942-RS11

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Arc Cut, Resection Block, Size 5
Paragon 28, Inc.
P10-942-RS05
In Commercial Distribution

  • 00889795063267 ()
P10-942-RS05

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Arc Cut, Resection Block, Size 4
Paragon 28, Inc.
P10-942-RS04
In Commercial Distribution

  • 00889795063250 ()
P10-942-RS04

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Arc Cut, Resection Block, Size 2
Paragon 28, Inc.
P10-942-RS02
In Commercial Distribution

  • 00889795063236 ()
P10-942-RS02

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Arc Cut, Resection Block, Size 1
Paragon 28, Inc.
P10-942-RS01
In Commercial Distribution

  • 00889795063229 ()
P10-942-RS01

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Flat/Flat, Resection Block Size 5
Paragon 28, Inc.
P10-942-FL15
In Commercial Distribution

  • 00889795063205 ()
P10-942-FL15

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Flat/Flat, Resection Block Size 2
Paragon 28, Inc.
P10-942-FL12
In Commercial Distribution

  • 00889795063175 ()
P10-942-FL12

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Flat/Flat, Resection Block Size 1
Paragon 28, Inc.
P10-942-FL11
In Commercial Distribution

  • 00889795063168 ()
P10-942-FL11

  • Orthopaedic prosthesis implantation positioning instrument, reusable
APEX 3D-PS Total Ankle Replacement System, Tibial Alignment Guide, Telescoping Rod
Paragon 28, Inc.
P10-941-AL01
In Commercial Distribution

  • 00889795062901 ()
P10-941-AL01

  • Orthopaedic fixation implant alignment tool
APEX 3D-PS Total Ankle Replacement System, Poly Trial Insert, Size 5, 11mm
Paragon 28, Inc.
P10-930-I511
In Commercial Distribution

  • 00889795062864 ()
P10-930-I511

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Poly Trial Insert, Size 4, 10mm
Paragon 28, Inc.
P10-930-I410
In Commercial Distribution

  • 00889795062789 ()
P10-930-I410

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Poly Trial Insert, Size 4, 6mm
Paragon 28, Inc.
P10-930-I406
In Commercial Distribution

  • 00889795062741 ()
P10-930-I406

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Poly Trial Insert, Size 3, 9mm
Paragon 28, Inc.
P10-930-I309
In Commercial Distribution

  • 00889795062703 ()
P10-930-I309

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Poly Trial Insert, Size 1, 8mm
Paragon 28, Inc.
P10-930-I108
In Commercial Distribution

  • 00889795062550 ()
P10-930-I108

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Trial Talus, Flat, Size 4, Right
Paragon 28, Inc.
P10-921-TLR4
In Commercial Distribution

  • 00889795062512 ()
P10-921-TLR4

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Trial Talus, Flat, Size 1, Left
Paragon 28, Inc.
P10-921-TLL1
In Commercial Distribution

  • 00889795062420 ()
P10-921-TLL1

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Trial Talus, Chamfer, Size 3, Right
Paragon 28, Inc.
P10-920-TLR3
In Commercial Distribution

  • 00889795062376 ()
P10-920-TLR3

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Trial Talus, Chamfer, Size 3, Left
Paragon 28, Inc.
P10-920-TLL3
In Commercial Distribution

  • 00889795062314 ()
P10-920-TLL3

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Trial Talus, Chamfer, Size 2, Left
Paragon 28, Inc.
P10-920-TLL2
In Commercial Distribution

  • 00889795062307 ()
P10-920-TLL2

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Trial Talus, Chamfer, Size 1 Narrow, Left
Paragon 28, Inc.
P10-920-TLL0
In Commercial Distribution

  • 00889795062284 ()
P10-920-TLL0

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Talar Fin Tower, Size 2-5
Paragon 28, Inc.
P10-920-TFT2
In Commercial Distribution

  • 00889795062277 ()
P10-920-TFT2

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Trial Tibia, FLAT, Size 6, Right
Paragon 28, Inc.
P10-911-TB6R
In Commercial Distribution

  • 00889795062253 ()
P10-911-TB6R

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Trial Tibia, FLAT, Size 5, Left
Paragon 28, Inc.
P10-911-TB5L
In Commercial Distribution

  • 00889795062222 ()
P10-911-TB5L

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Trial Tibia, FLAT, Size 4, Left
Paragon 28, Inc.
P10-911-TB4L
In Commercial Distribution

  • 00889795062208 ()
P10-911-TB4L

  • Surgical implant template, reusable
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