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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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Grappler Interference Screw System - 00889795146007

PCFD Tether, Suture Retriever
Paragon 28, Inc.
P62-910-0010
In Commercial Distribution

  • 00889795146007 ()
P62-910-0010

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Baby Gorilla/Gorilla Plating System - 00889795145451

Drill Guide Sleeve, 2.7mm, R3CON
Paragon 28, Inc.
P51-913-2027-03
In Commercial Distribution

  • 00889795145451 ()
P51-913-2027-03

  • Surgical drill guide, reusable

APEX 3D Total Ankle Replacement System - 00889795143877

TOTAL ANKLE IMPLANT, INSERT, SIZE 5, 10 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I510-S
In Commercial Distribution

  • 00889795143877 ()
P10-310-I510-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143860

TOTAL ANKLE IMPLANT, INSERT, SIZE 5, 9 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I509-S
In Commercial Distribution

  • 00889795143860 ()
P10-310-I509-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143846

TOTAL ANKLE IMPLANT, INSERT, SIZE 5, 7 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I507-S
In Commercial Distribution

  • 00889795143846 ()
P10-310-I507-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143822

TOTAL ANKLE IMPLANT, INSERT, SIZE 4, 20 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I420-S
In Commercial Distribution

  • 00889795143822 ()
P10-310-I420-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143815

TOTAL ANKLE IMPLANT, INSERT, SIZE 4, 18 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I418-S
In Commercial Distribution

  • 00889795143815 ()
P10-310-I418-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143808

TOTAL ANKLE IMPLANT, INSERT, SIZE 4, 16 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I416-S
In Commercial Distribution

  • 00889795143808 ()
P10-310-I416-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143792

TOTAL ANKLE IMPLANT, INSERT, SIZE 4, 14 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I414-S
In Commercial Distribution

  • 00889795143792 ()
P10-310-I414-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143785

TOTAL ANKLE IMPLANT, INSERT, SIZE 4, 12 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I412-S
In Commercial Distribution

  • 00889795143785 ()
P10-310-I412-S

  • Fixed-bearing total ankle prosthesis
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