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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 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 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 3
Paragon 28, Inc.
P10-942-RS13
In Commercial Distribution

  • 00889795063304 ()
P10-942-RS13

  • 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
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 6
Paragon 28, Inc.
P10-942-RS06
In Commercial Distribution

  • 00889795063274 ()
P10-942-RS06

  • 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 3
Paragon 28, Inc.
P10-942-RS03
In Commercial Distribution

  • 00889795063243 ()
P10-942-RS03

  • 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 6
Paragon 28, Inc.
P10-942-FL16
In Commercial Distribution

  • 00889795063212 ()
P10-942-FL16

  • 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 4
Paragon 28, Inc.
P10-942-FL14
In Commercial Distribution

  • 00889795063199 ()
P10-942-FL14

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Flat/Flat, Resection Block Size 3
Paragon 28, Inc.
P10-942-FL13
In Commercial Distribution

  • 00889795063182 ()
P10-942-FL13

  • 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
Tibial Flat Cut, Resection Block, Size 6
Paragon 28, Inc.
P10-942-FL06
In Commercial Distribution

  • 00889795063151 ()
P10-942-FL06

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Flat Cut, Resection Block, Size 5
Paragon 28, Inc.
P10-942-FL05
In Commercial Distribution

  • 00889795063144 ()
P10-942-FL05

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Flat Cut, Resection Block, Size 4
Paragon 28, Inc.
P10-942-FL04
In Commercial Distribution

  • 00889795063137 ()
P10-942-FL04

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Flat Cut, Resection Block, Size 3
Paragon 28, Inc.
P10-942-FL03
In Commercial Distribution

  • 00889795063120 ()
P10-942-FL03

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Flat Cut, Resection Block, Size 2
Paragon 28, Inc.
P10-942-FL02
In Commercial Distribution

  • 00889795063113 ()
P10-942-FL02

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Flat Cut, Resection Block, Size 1
Paragon 28, Inc.
P10-942-FL01
In Commercial Distribution

  • 00889795063106 ()
P10-942-FL01

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Talar Decoupled Resection, Body, Small
Paragon 28, Inc.
P10-942-DTSM
In Commercial Distribution

  • 00889795063090 ()
P10-942-DTSM

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Talar Decoupled Resection, Split Shim, +7mm, Flat
Paragon 28, Inc.
P10-942-DT17
In Commercial Distribution

  • 00889795063076 ()
P10-942-DT17

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Talar Decoupled Resection, Split Shim, +6mm
Paragon 28, Inc.
P10-942-DT16
In Commercial Distribution

  • 00889795063069 ()
P10-942-DT16

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Talar Decoupled Resection, Split Shim, +5mm
Paragon 28, Inc.
P10-942-DT15
In Commercial Distribution

  • 00889795063052 ()
P10-942-DT15

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Talar Decoupled Resection, Split Shim, +4mm
Paragon 28, Inc.
P10-942-DT14
In Commercial Distribution

  • 00889795063045 ()
P10-942-DT14

  • 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
Talar Decoupled Resection, Split Shim, +1mm
Paragon 28, Inc.
P10-942-DT11
In Commercial Distribution

  • 00889795063014 ()
P10-942-DT11

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Top Hat, Ø3.5mm
Paragon 28, Inc.
P10-942-35TH
In Commercial Distribution

  • 00889795063007 ()
P10-942-35TH

  • 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, Joint Line Reference Wing
Paragon 28, Inc.
P10-941-AW01
In Commercial Distribution

  • 00889795062970 ()
P10-941-AW01

  • Orthopaedic fixation implant alignment tool
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
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