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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Talar Recut Guide Posterior Cut
Paragon 28, Inc.
P10-944-TCR2
In Commercial Distribution

  • 00889795063694 ()
P10-944-TCR2

  • Osteotomy guide, reusable
Talar Recut Guide 2mm Dorsal Cut
Paragon 28, Inc.
P10-944-TCR1
In Commercial Distribution

  • 00889795063687 ()
P10-944-TCR1

  • Osteotomy guide, reusable
APEX 3D-PS Total Ankle Replacement System, Chamfer Checker, AP Double-Ended, SS
Paragon 28, Inc.
P10-944-TCC2
In Commercial Distribution

  • 00889795063670 ()
P10-944-TCC2

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Chamfer Checker, All-in-one, SS
Paragon 28, Inc.
P10-944-TCC1
In Commercial Distribution

  • 00889795063663 ()
P10-944-TCC1

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Square Tip Ronguer
Paragon 28, Inc.
P10-944-STR0
In Commercial Distribution

  • 00889795063656 ()
P10-944-STR0

  • Orthopaedic joint/limb rongeur
APEX 3D-PS Total Ankle Replacement System, Talar PSI Resection Block, Size 4 & 5
Paragon 28, Inc.
P10-944-PSI3
In Commercial Distribution

  • 00889795063649 ()
P10-944-PSI3

  • Osteotomy guide, reusable
APEX 3D-PS Total Ankle Replacement System, Talar PSI Resection Block, Size 2 & 3
Paragon 28, Inc.
P10-944-PSI2
In Commercial Distribution

  • 00889795063632 ()
P10-944-PSI2

  • Osteotomy guide, reusable
APEX 3D-PS Total Ankle Replacement System, Talar PSI Resection Block, Size 1 Narrow & 1
Paragon 28, Inc.
P10-944-PSI1
In Commercial Distribution

  • 00889795063625 ()
P10-944-PSI1

  • Osteotomy guide, reusable
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, 2-Holed, Size 5
Paragon 28, Inc.
P10-944-LL25
In Commercial Distribution

  • 00889795063618 ()
P10-944-LL25

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, 2-Holed, Size 4
Paragon 28, Inc.
P10-944-LL24
In Commercial Distribution

  • 00889795063601 ()
P10-944-LL24

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, 2-Holed, Size 3
Paragon 28, Inc.
P10-944-LL23
In Commercial Distribution

  • 00889795063595 ()
P10-944-LL23

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, 2-Holed, Size 2
Paragon 28, Inc.
P10-944-LL22
In Commercial Distribution

  • 00889795063588 ()
P10-944-LL22

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, 2-Holed, Size 1
Paragon 28, Inc.
P10-944-LL21
In Commercial Distribution

  • 00889795063571 ()
P10-944-LL21

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, 2-Holed, Size 1 Narrow
Paragon 28, Inc.
P10-944-LL20
In Commercial Distribution

  • 00889795063564 ()
P10-944-LL20

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, Single-Slotted, Size 5
Paragon 28, Inc.
P10-944-LL15
In Commercial Distribution

  • 00889795063557 ()
P10-944-LL15

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, Single-Slotted, Size 4
Paragon 28, Inc.
P10-944-LL14
In Commercial Distribution

  • 00889795063540 ()
P10-944-LL14

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, Single-Slotted, Size 3
Paragon 28, Inc.
P10-944-LL13
In Commercial Distribution

  • 00889795063533 ()
P10-944-LL13

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, Single-Slotted, Size 2
Paragon 28, Inc.
P10-944-LL12
In Commercial Distribution

  • 00889795063526 ()
P10-944-LL12

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, Single-Slotted, Size 1
Paragon 28, Inc.
P10-944-LL11
In Commercial Distribution

  • 00889795063519 ()
P10-944-LL11

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, Single-Slotted, Size 1 Narrow
Paragon 28, Inc.
P10-944-LL10
In Commercial Distribution

  • 00889795063502 ()
P10-944-LL10

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Talar Sizing Resection Guide, Chamfer, Size 5
Paragon 28, Inc.
P10-944-LL05
In Commercial Distribution

  • 00889795063496 ()
P10-944-LL05

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Talar Sizing Resection Guide, Chamfer, Size 4
Paragon 28, Inc.
P10-944-LL04
In Commercial Distribution

  • 00889795063489 ()
P10-944-LL04

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Talar Sizing Resection Guide, Chamfer, Size 3
Paragon 28, Inc.
P10-944-LL03
In Commercial Distribution

  • 00889795063472 ()
P10-944-LL03

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Talar Sizing Resection Guide, Chamfer, Size 2
Paragon 28, Inc.
P10-944-LL02
In Commercial Distribution

  • 00889795063465 ()
P10-944-LL02

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Talar Sizing Resection Guide, Chamfer, Size 1
Paragon 28, Inc.
P10-944-LL01
In Commercial Distribution

  • 00889795063458 ()
P10-944-LL01

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Talar Sizing Resection Guide, Chamfer, Size 1 Narrow
Paragon 28, Inc.
P10-944-LL00
In Commercial Distribution

  • 00889795063441 ()
P10-944-LL00

  • Surgical implant template, reusable
APEX 3D-PS Total Ankle Replacement System, Talar Peg Router
Paragon 28, Inc.
P10-944-4013
In Commercial Distribution

  • 00889795063434 ()
P10-944-4013

  • Bone-resection orthopaedic reamer, reusable
APEX 3D-PS Total Ankle Replacement System, Talar Chamfer Resection Router, Ø13mm
Paragon 28, Inc.
P10-944-1375
In Commercial Distribution

  • 00889795063427 ()
P10-944-1375

  • Bone-resection orthopaedic reamer, reusable
APEX 3D-PS Total Ankle Replacement System, Talar Chamfer Resection Router, Ø11mm
Paragon 28, Inc.
P10-944-1175
In Commercial Distribution

  • 00889795063410 ()
P10-944-1175

  • Bone-resection orthopaedic reamer, reusable
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 6
Paragon 28, Inc.
P10-942-SZ06
In Commercial Distribution

  • 00889795063397 ()
P10-942-SZ06

  • Orthopaedic prosthesis implantation positioning instrument, 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 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
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