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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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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 3
Paragon 28, Inc.
P10-942-SZ03
In Commercial Distribution

  • 00889795063366 ()
P10-942-SZ03

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Sizing Resection Block, Size 2
Paragon 28, Inc.
P10-942-SZ02
In Commercial Distribution

  • 00889795063359 ()
P10-942-SZ02

  • 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 5
Paragon 28, Inc.
P10-942-RS15
In Commercial Distribution

  • 00889795063328 ()
P10-942-RS15

  • 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 2
Paragon 28, Inc.
P10-942-RS12
In Commercial Distribution

  • 00889795063298 ()
P10-942-RS12

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Talar Decoupled Resection, Split Shim, +3mm, Chamfer
Paragon 28, Inc.
P10-942-DT13
In Commercial Distribution

  • 00889795063038 ()
P10-942-DT13

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Talar Decoupled Resection, Split Shim, +2mm
Paragon 28, Inc.
P10-942-DT12
In Commercial Distribution

  • 00889795063021 ()
P10-942-DT12

  • Orthopaedic prosthesis implantation positioning instrument, reusable
APEX 3D-PS Total Ankle Replacement System, Arc Resection Drill, SS, Ø3.5MM
Paragon 28, Inc.
P10-942-3513
In Commercial Distribution

  • 00889795062994 ()
P10-942-3513

  • Fluted surgical drill bit, single-use
APEX 3D-PS Total Ankle Replacement System, Tibial Alignment Guide, Joint Line Pointer ("JLP")
Paragon 28, Inc.
P10-941-AL07
In Commercial Distribution

  • 00889795062963 ()
P10-941-AL07

  • Orthopaedic fixation implant alignment tool
APEX 3D-PS Total Ankle Replacement System, Tibial Alignment Guide, Lateral Rod
Paragon 28, Inc.
P10-941-AL04
In Commercial Distribution

  • 00889795062932 ()
P10-941-AL04

  • Orthopaedic fixation implant alignment tool
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
Joint-Line, Alignment, Pin Tube
Paragon 28, Inc.
P10-940-JL10
In Commercial Distribution

  • 00889795062895 ()
P10-940-JL10

  • Orthopaedic fixation implant alignment tool
APEX 3D-PS Total Ankle Replacement System, Poly Trial Insert, Size 5, 12mm
Paragon 28, Inc.
P10-930-I512
In Commercial Distribution

  • 00889795062871 ()
P10-930-I512

  • Surgical implant template, reusable
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 5, 9mm
Paragon 28, Inc.
P10-930-I509
In Commercial Distribution

  • 00889795062840 ()
P10-930-I509

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Poly Trial Insert, Size 5, 8mm
Paragon 28, Inc.
P10-930-I508
In Commercial Distribution

  • 00889795062833 ()
P10-930-I508

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Poly Trial Insert, Size 5, 7mm
Paragon 28, Inc.
P10-930-I507
In Commercial Distribution

  • 00889795062826 ()
P10-930-I507

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Poly Trial Insert, Size 4, 12mm
Paragon 28, Inc.
P10-930-I412
In Commercial Distribution

  • 00889795062802 ()
P10-930-I412

  • Surgical implant template, reusable
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