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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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Gorilla, Ankle Fx., Medial Distal Tibia Plate, 17-Holes, TiA
Paragon 28, Inc.
P53-214-1010
In Commercial Distribution

  • 00889795099167 ()
P53-214-1010

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Medial Distal Tibia Plate, 15-Holes, TiA
Paragon 28, Inc.
P53-214-1008
In Commercial Distribution

  • 00889795099150 ()
P53-214-1008

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Medial Distal Tibia Plate, 13-Holes, TiA
Paragon 28, Inc.
P53-214-1006
In Commercial Distribution

  • 00889795099143 ()
P53-214-1006

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Medial Distal Tibia Plate, 11-Holes, TiA
Paragon 28, Inc.
P53-214-1004
In Commercial Distribution

  • 00889795099136 ()
P53-214-1004

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterior Distal Tibi Plate, 15 Hole, TiA
Paragon 28, Inc.
P53-212-0006
In Commercial Distribution

  • 00889795099129 ()
P53-212-0006

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterior Distal Tibia Plate, 13 Hole, TiA
Paragon 28, Inc.
P53-212-0004
In Commercial Distribution

  • 00889795099112 ()
P53-212-0004

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterior Distal Tibia Plate, 11 Hole, TiA
Paragon 28, Inc.
p53-212-0002
In Commercial Distribution

  • 00889795099105 ()
p53-212-0002

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Forceps, Bone Holding w/ Locking Wheel
Paragon 28, Inc.
P99-150-0083
In Commercial Distribution

  • 00889795099082 ()
P99-150-0083

  • Dressing/utility forceps, scissors-like, reusable
APEX 3D-PS Total Ankle Replacement System, Case Lid
Paragon 28, Inc.
P10-900-CASL
In Commercial Distribution

  • 00889795099051 ()
P10-900-CASL

  • Device sterilization/disinfection container, reusable
APEX 3D-PS Total Ankle Replacement System, Case Base
Paragon 28, Inc.
P10-900-CASB
In Commercial Distribution

  • 00889795099044 ()
P10-900-CASB

  • Device sterilization/disinfection container, reusable
APEX 3D-PS Total Ankle Replacement System, Small Tray
Paragon 28, Inc.
P10-900-0007
In Commercial Distribution

  • 00889795099013 ()
P10-900-0007

  • Device sterilization/disinfection container, reusable
APEX 3D-PS Total Ankle Replacement System, Large Instrumentation, Tray
Paragon 28, Inc.
P10-900-0006
In Commercial Distribution

  • 00889795099006 ()
P10-900-0006

  • Device sterilization/disinfection container, reusable
APEX 3D-PS Total Ankle Replacement System, Impaction, Tray
Paragon 28, Inc.
P10-900-0005
In Commercial Distribution

  • 00889795098993 ()
P10-900-0005

  • Device sterilization/disinfection container, reusable
APEX 3D-PS Total Ankle Replacement System, Talus Trialing, Tray
Paragon 28, Inc.
P10-900-0004
In Commercial Distribution

  • 00889795098986 ()
P10-900-0004

  • Device sterilization/disinfection container, reusable
APEX 3D-PS Total Ankle Replacement System, Tibia Trialing, Tray
Paragon 28, Inc.
P10-900-0003
In Commercial Distribution

  • 00889795098979 ()
P10-900-0003

  • Device sterilization/disinfection container, reusable
APEX 3D-PS Total Ankle Replacement System, Resection, Tray
Paragon 28, Inc.
P10-900-0002
In Commercial Distribution

  • 00889795098962 ()
P10-900-0002

  • Device sterilization/disinfection container, reusable
APEX 3D-PS Total Ankle Replacement System, Alignment, Tray
Paragon 28, Inc.
P10-900-0001
In Commercial Distribution

  • 00889795098955 ()
P10-900-0001

  • Device sterilization/disinfection container, reusable
Total Ankle, Instrument, Alignment, Guide, PSI Alignment Rod
Paragon 28, Inc.
P10-941-PSI1
In Commercial Distribution

  • 00889795098948 ()
P10-941-PSI1

  • Orthopaedic fixation implant alignment tool
APEX 3D-PS Total Ankle Replacement System, Poly Insertion Tool
Paragon 28, Inc.
P10-951-IN02
In Commercial Distribution

  • 00889795098931 ()
P10-951-IN02

  • Orthopaedic inorganic implant inserter/extractor, reusable
Total Ankle, Instrument, Socket Driver
Paragon 28, Inc.
P10-910-SCKT
In Commercial Distribution

  • 00889795098924 ()
P10-910-SCKT

  • Surgical screwdriver, reusable
Dynamic Syndesmosis Screw Ø4.2 X 60mm, 17mm Notch, Sterile
Paragon 28, Inc.
P80-142-1760-S
In Commercial Distribution

  • 00889795098481 ()
P80-142-1760-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Dynamic Syndesmosis Screw Ø4.2 X 55mm, 17mm Notch, Sterile
Paragon 28, Inc.
P80-142-1755-S
In Commercial Distribution

  • 00889795098474 ()
P80-142-1755-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Dynamic Syndesmosis Screw Ø4.2 X 50mm, 17mm Notch, Sterile
Paragon 28, Inc.
P80-142-1750-S
In Commercial Distribution

  • 00889795098467 ()
P80-142-1750-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Dynamic Syndesmosis Screw Ø4.2 X 45mm, 17mm Notch, Sterile
Paragon 28, Inc.
P80-142-1745-S
In Commercial Distribution

  • 00889795098450 ()
P80-142-1745-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Dynamic Syndesmosis Screw Ø4.2 X 40mm, 17mm Notch, Sterile
Paragon 28, Inc.
P80-142-1740-S
In Commercial Distribution

  • 00889795098443 ()
P80-142-1740-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Dynamic Syndesmosis Screw Ø4.2 X 60mm, 14mm Notch, Sterile
Paragon 28, Inc.
P80-142-1460-S
In Commercial Distribution

  • 00889795098436 ()
P80-142-1460-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Dynamic Syndesmosis Screw Ø4.2 X 55mm, 14mm Notch, Sterile
Paragon 28, Inc.
P80-142-1455-S
In Commercial Distribution

  • 00889795098429 ()
P80-142-1455-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Dynamic Syndesmosis Screw Ø4.2 X 50mm, 14mm Notch, Sterile
Paragon 28, Inc.
P80-142-1450-S
In Commercial Distribution

  • 00889795098412 ()
P80-142-1450-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Dynamic Syndesmosis Screw Ø4.2 X 45mm, 14mm Notch, Sterile
Paragon 28, Inc.
P80-142-1445-S
In Commercial Distribution

  • 00889795098405 ()
P80-142-1445-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Dynamic Syndesmosis Screw Ø4.2 X 40mm, 14mm Notch, Sterile
Paragon 28, Inc.
P80-142-1440-S
In Commercial Distribution

  • 00889795098399 ()
P80-142-1440-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
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