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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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Paragon 28 Bone Wedge System - 00889795120540

AO 2.2MM DRILL BIT
Paragon 28, Inc.
AOHT22
In Commercial Distribution

  • 00889795120540 ()
AOHT22

  • Cannulated surgical drill bit, reusable

Paragon 28 Bone Wedge System - 00889795120533

AO 2.0MM DRILL BIT
Paragon 28, Inc.
AOHT20
In Commercial Distribution

  • 00889795120533 ()
AOHT20

  • Cannulated surgical drill bit, reusable

Grappler™ Suture Anchor System - 00889795119025

5.5mm cannulated tap, chronic anchor
Paragon 28, Inc.
P44-960-1055-S
In Commercial Distribution

  • 00889795119025 ()
P44-960-1055-S

  • Bone tap, single-use

Grappler™ Suture Anchor System - 00889795119018

4.5mm cannulated tap, chronic anchor
Paragon 28, Inc.
P44-960-1045-S
In Commercial Distribution

  • 00889795119018 ()
P44-960-1045-S

  • Bone tap, single-use

APEX 3D Total Ankle Replacement System - 00889795119001

Total Ankle Replacement System, Offset Poly Trial Case
Paragon 28, Inc.
P10-900-APTR
In Commercial Distribution

  • 00889795119001 ()
P10-900-APTR

  • Device sterilization/disinfection container, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795118929

Joint Preparation Rasp, Square, 17mm x 17mm
Paragon 28, Inc.
P99-150-1217
In Commercial Distribution

  • 00889795118929 ()
P99-150-1217

  • Bone file/rasp, manual, reusable

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
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