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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™ Cross-linked Vitamin E POLY, SIZE 3 x 10MM, NEUTRAL
Paragon 28, Inc.
P10-310-I310-S
In Commercial Distribution

  • 00889795073617 ()
P10-310-I310-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 9MM, NEUTRAL
Paragon 28, Inc.
P10-310-I309-S
In Commercial Distribution

  • 00889795073600 ()
P10-310-I309-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 8MM, NEUTRAL
Paragon 28, Inc.
P10-310-I308-S
In Commercial Distribution

  • 00889795073594 ()
P10-310-I308-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 7MM, NEUTRAL
Paragon 28, Inc.
P10-310-I307-S
In Commercial Distribution

  • 00889795073587 ()
P10-310-I307-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 16MM, NEUTRAL
Paragon 28, Inc.
P10-310-I216-S
In Commercial Distribution

  • 00889795072320 ()
P10-310-I216-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 10MM, NEUTRAL
Paragon 28, Inc.
P10-310-I210-S
In Commercial Distribution

  • 00889795072269 ()
P10-310-I210-S

  • Fixed-bearing total ankle prosthesis
APEX 3D-PS Total Ankle Replacement System, Tibia Impaction Peg Punch, Left, Size 6
Paragon 28, Inc.
P10-951-TPL6
In Commercial Distribution

  • 00889795063991 ()
P10-951-TPL6

  • Bone-coring punch, reusable
APEX 3D-PS Total Ankle Replacement System, Tibia Impaction Peg Punch, Left, Size 3
Paragon 28, Inc.
P10-951-TPL3
In Commercial Distribution

  • 00889795063960 ()
P10-951-TPL3

  • Bone-coring punch, reusable
APEX 3D-PS Total Ankle Replacement System, Tibia Impaction Peg Punch, Left, Size 2
Paragon 28, Inc.
P10-951-TPL2
In Commercial Distribution

  • 00889795063953 ()
P10-951-TPL2

  • Bone-coring punch, reusable
APEX 3D-PS Total Ankle Replacement System, Tibia Impaction Protector, Size 6
Paragon 28, Inc.
P10-951-TP06
In Commercial Distribution

  • 00889795063939 ()
P10-951-TP06

  • Orthopaedic implant impactor, reusable
APEX 3D-PS Total Ankle Replacement System, Tibia Impaction Protector, Size 2
Paragon 28, Inc.
P10-951-TP02
In Commercial Distribution

  • 00889795063892 ()
P10-951-TP02

  • Orthopaedic implant impactor, reusable
APEX 3D-PS Total Ankle Replacement System, 4-Bar Distractor, Viper Tip, Size 4, SS
Paragon 28, Inc.
P10-951-TBV4
In Commercial Distribution

  • 00889795063854 ()
P10-951-TBV4

  • Orthopaedic surgical distractor, internal
APEX 3D-PS Total Ankle Replacement System, 4-Bar Distractor, Viper Tip, Size 2, SS
Paragon 28, Inc.
P10-951-TBV2
In Commercial Distribution

  • 00889795063830 ()
P10-951-TBV2

  • Orthopaedic surgical distractor, internal
APEX 3D-PS Total Ankle Replacement System, Tibia Impaction Coin, Right
Paragon 28, Inc.
P10-951-TBR2
In Commercial Distribution

  • 00889795063816 ()
P10-951-TBR2

  • Orthopaedic implant impactor, reusable
APEX 3D-PS Total Ankle Replacement System, Tibia Impaction Handle
Paragon 28, Inc.
P10-951-TB00
In Commercial Distribution

  • 00889795063779 ()
P10-951-TB00

  • Surgical instrument handle, non-torque-limiting
APEX 3D-PS Total Ankle Replacement System, 4-Bar Distractor, Talus Paddle, Size 1 Narrow & 1
Paragon 28, Inc.
P10-951-P011
In Commercial Distribution

  • 00889795063731 ()
P10-951-P011

  • Orthopaedic surgical distractor, internal
Talar Recut Guide Posterior Cut
Paragon 28, Inc.
P10-944-TCR2
In Commercial Distribution

  • 00889795063694 ()
P10-944-TCR2

  • Osteotomy guide, 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 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, 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, 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 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 Peg Router
Paragon 28, Inc.
P10-944-4013
In Commercial Distribution

  • 00889795063434 ()
P10-944-4013

  • Bone-resection orthopaedic reamer, reusable
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