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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R3CON Locking Screw Ø2.70 x 58mm
Paragon 28, Inc.
P50-353-2758
In Commercial Distribution

  • 00889795099549 ()
P50-353-2758

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Locking Screw Ø2.70 x 56mm
Paragon 28, Inc.
P50-353-2756
In Commercial Distribution

  • 00889795099532 ()
P50-353-2756

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Locking Screw Ø2.70 x 55mm
Paragon 28, Inc.
P50-353-2755
In Commercial Distribution

  • 00889795099525 ()
P50-353-2755

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Locking Screw Ø2.70 x 54mm
Paragon 28, Inc.
P50-353-2754
In Commercial Distribution

  • 00889795099518 ()
P50-353-2754

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Locking Screw Ø2.70 x 52mm
Paragon 28, Inc.
P50-353-2752
In Commercial Distribution

  • 00889795099501 ()
P50-353-2752

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Locking Screw Ø2.70 x 50mm
Paragon 28, Inc.
P50-353-2750
In Commercial Distribution

  • 00889795099495 ()
P50-353-2750

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Locking Screw Ø2.70 x 48mm
Paragon 28, Inc.
P50-353-2748
In Commercial Distribution

  • 00889795099488 ()
P50-353-2748

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Locking Screw Ø2.70 x 46mm
Paragon 28, Inc.
P50-353-2746
In Commercial Distribution

  • 00889795099464 ()
P50-353-2746

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Locking Screw Ø2.70 x 45mm
Paragon 28, Inc.
P50-353-2745
In Commercial Distribution

  • 00889795099457 ()
P50-353-2745

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Locking Screw Ø2.70 x 44mm
Paragon 28, Inc.
P50-353-2744
In Commercial Distribution

  • 00889795099440 ()
P50-353-2744

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Locking Screw, Ø2.70 x 42mm
Paragon 28, Inc.
P50-353-2742
In Commercial Distribution

  • 00889795099433 ()
P50-353-2742

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Left, 25-Holes, TiA
Paragon 28, Inc.
P53-213-L018
In Commercial Distribution

  • 00889795099358 ()
P53-213-L018

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Left, 23-Holes, TiA
Paragon 28, Inc.
P53-213-L016
In Commercial Distribution

  • 00889795099341 ()
P53-213-L016

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Left, 21-Holes, TiA
Paragon 28, Inc.
P53-213-L014
In Commercial Distribution

  • 00889795099334 ()
P53-213-L014

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Left, 19-Holes, TiA
Paragon 28, Inc.
P53-213-L012
In Commercial Distribution

  • 00889795099327 ()
P53-213-L012

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Left, 17-Holes, TiA
Paragon 28, Inc.
P53-213-L010
In Commercial Distribution

  • 00889795099310 ()
P53-213-L010

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Left, 15-Holes, TiA
Paragon 28, Inc.
P53-213-L008
In Commercial Distribution

  • 00889795099303 ()
P53-213-L008

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Left, 13-Holes, TiA
Paragon 28, Inc.
P53-213-L006
In Commercial Distribution

  • 00889795099297 ()
P53-213-L006

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Left, 11-Holes, TiA
Paragon 28, Inc.
P53-213-L004
In Commercial Distribution

  • 00889795099280 ()
P53-213-L004

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Right, 25-Holes, TiA
Paragon 28, Inc.
P53-213-R018
In Commercial Distribution

  • 00889795099273 ()
P53-213-R018

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Right, 23-Holes, TiA
Paragon 28, Inc.
P53-213-R016
In Commercial Distribution

  • 00889795099266 ()
P53-213-R016

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Right, 21-Holes, TiA
Paragon 28, Inc.
P53-213-R014
In Commercial Distribution

  • 00889795099259 ()
P53-213-R014

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Right, 19-Holes, TiA
Paragon 28, Inc.
P53-213-R012
In Commercial Distribution

  • 00889795099242 ()
P53-213-R012

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Right, 17-Holes, TiA
Paragon 28, Inc.
P53-213-R010
In Commercial Distribution

  • 00889795099235 ()
P53-213-R010

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Right, 15-Holes, TiA
Paragon 28, Inc.
P53-213-R008
In Commercial Distribution

  • 00889795099228 ()
P53-213-R008

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Right, 13-Holes, TiA
Paragon 28, Inc.
P53-213-R006
In Commercial Distribution

  • 00889795099211 ()
P53-213-R006

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Right, 11-Holes, TiA
Paragon 28, Inc.
P53-213-R004
In Commercial Distribution

  • 00889795099204 ()
P53-213-R004

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Medial Distal Tibia Plate, 23-Holes, TiA
Paragon 28, Inc.
P53-214-1016
In Commercial Distribution

  • 00889795099198 ()
P53-214-1016

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Medial Distal Tibia Plate, 21-Holes, TiA
Paragon 28, Inc.
P53-214-1014
In Commercial Distribution

  • 00889795099181 ()
P53-214-1014

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Medial Distal Tibia Plate, 19-Holes, TiA
Paragon 28, Inc.
P53-214-1012
In Commercial Distribution

  • 00889795099174 ()
P53-214-1012

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
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
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