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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 Total Ankle Replacement System - 00889795119551

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 13MM, 3.5MM POST OFFSET
Paragon 28, Inc.
P10-31P-I313-S
In Commercial Distribution

  • 00889795119551 ()
P10-31P-I313-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795119483

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 16MM, 3.5MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I316-S
In Commercial Distribution

  • 00889795119483 ()
P10-31A-I316-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795119391

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 17MM, 3.25MM POST OFFSET
Paragon 28, Inc.
P10-31P-I217-S
In Commercial Distribution

  • 00889795119391 ()
P10-31P-I217-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795118516

APEX 3D-PS Total Ankle Replacement System, Dorsal Talar Recut Guide, 4mm Large
Paragon 28, Inc.
P10-844-04LG
In Commercial Distribution

  • 00889795118516 ()
P10-844-04LG

  • Osteotomy guide, reusable

APEX 3D Total Ankle Replacement System - 00889795118509

APEX 3D-PS Total Ankle Replacement System, Dorsal Talar Recut Guide, 4mm Small
Paragon 28, Inc.
P10-844-04SM
In Commercial Distribution

  • 00889795118509 ()
P10-844-04SM

  • Osteotomy guide, reusable

APEX 3D Total Ankle Replacement System - 00889795118493

APEX 3D-PS Total Ankle Replacement System, Dorsal Talar Recut Guide, 2mm Large
Paragon 28, Inc.
P10-844-02LG
In Commercial Distribution

  • 00889795118493 ()
P10-844-02LG

  • Osteotomy guide, reusable

APEX 3D Total Ankle Replacement System - 00889795118486

APEX 3D-PS Total Ankle Replacement System, Dorsal Talar Recut Guide, 2mm Small
Paragon 28, Inc.
P10-844-02SM
In Commercial Distribution

  • 00889795118486 ()
P10-844-02SM

  • Osteotomy guide, reusable

Paratrooper™ Plantar Plate Repair System - 00889795118479

Paratrooper Plantar Plate Repair System, Implant Only Kit- Sterile
Paragon 28, Inc.
P13-000-5016-S
In Commercial Distribution

  • 00889795118479 ()
P13-000-5016-S

  • Suturing unit, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795118349

Phantom TTC Nail, 13.0 X 250mm, RIGHT Sterile Packaged
Paragon 28, Inc.
P31-630-250R-S
In Commercial Distribution

  • 00889795118349 ()
P31-630-250R-S

  • Arthrodesis intramedullary nail, non-distracting

Phantom Hindfoot TTC/TC Nail System - 00889795118332

Phantom TTC Nail, 13.0 X 250mm, LEFT Sterile Packaged
Paragon 28, Inc.
P31-630-250L-S
In Commercial Distribution

  • 00889795118332 ()
P31-630-250L-S

  • Arthrodesis intramedullary nail, non-distracting
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