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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 - 00889795062512

APEX 3D-PS Total Ankle Replacement System, Trial Talus, Flat, Size 4, Right
Paragon 28, Inc.
P10-921-TLR4
In Commercial Distribution

  • 00889795062512 ()
P10-921-TLR4

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062420

APEX 3D-PS Total Ankle Replacement System, Trial Talus, Flat, Size 1, Left
Paragon 28, Inc.
P10-921-TLL1
In Commercial Distribution

  • 00889795062420 ()
P10-921-TLL1

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062376

APEX 3D-PS Total Ankle Replacement System, Trial Talus, Chamfer, Size 3, Right
Paragon 28, Inc.
P10-920-TLR3
In Commercial Distribution

  • 00889795062376 ()
P10-920-TLR3

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062314

APEX 3D-PS Total Ankle Replacement System, Trial Talus, Chamfer, Size 3, Left
Paragon 28, Inc.
P10-920-TLL3
In Commercial Distribution

  • 00889795062314 ()
P10-920-TLL3

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062307

APEX 3D-PS Total Ankle Replacement System, Trial Talus, Chamfer, Size 2, Left
Paragon 28, Inc.
P10-920-TLL2
In Commercial Distribution

  • 00889795062307 ()
P10-920-TLL2

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062284

APEX 3D-PS Total Ankle Replacement System, Trial Talus, Chamfer, Size 1 Narrow, Left
Paragon 28, Inc.
P10-920-TLL0
In Commercial Distribution

  • 00889795062284 ()
P10-920-TLL0

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062277

APEX 3D-PS Total Ankle Replacement System, Talar Fin Tower, Size 2-5
Paragon 28, Inc.
P10-920-TFT2
In Commercial Distribution

  • 00889795062277 ()
P10-920-TFT2

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062253

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, FLAT, Size 6, Right
Paragon 28, Inc.
P10-911-TB6R
In Commercial Distribution

  • 00889795062253 ()
P10-911-TB6R

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062222

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, FLAT, Size 5, Left
Paragon 28, Inc.
P10-911-TB5L
In Commercial Distribution

  • 00889795062222 ()
P10-911-TB5L

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062208

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, FLAT, Size 4, Left
Paragon 28, Inc.
P10-911-TB4L
In Commercial Distribution

  • 00889795062208 ()
P10-911-TB4L

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062192

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, FLAT, Size 3, Right
Paragon 28, Inc.
P10-911-TB3R
In Commercial Distribution

  • 00889795062192 ()
P10-911-TB3R

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062185

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, FLAT, Size 3, Left
Paragon 28, Inc.
P10-911-TB3L
In Commercial Distribution

  • 00889795062185 ()
P10-911-TB3L

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062178

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, FLAT, Size 2, Right
Paragon 28, Inc.
P10-911-TB2R
In Commercial Distribution

  • 00889795062178 ()
P10-911-TB2R

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062161

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, FLAT, Size 2, Left
Paragon 28, Inc.
P10-911-TB2L
In Commercial Distribution

  • 00889795062161 ()
P10-911-TB2L

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062154

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, FLAT, Size 1, Right
Paragon 28, Inc.
P10-911-TB1R
In Commercial Distribution

  • 00889795062154 ()
P10-911-TB1R

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062147

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, FLAT, Size 1, Left
Paragon 28, Inc.
P10-911-TB1L
In Commercial Distribution

  • 00889795062147 ()
P10-911-TB1L

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062130

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 6, Right
Paragon 28, Inc.
P10-910-TB6R
In Commercial Distribution

  • 00889795062130 ()
P10-910-TB6R

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062123

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 6, Left
Paragon 28, Inc.
P10-910-TB6L
In Commercial Distribution

  • 00889795062123 ()
P10-910-TB6L

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062116

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 5, Right
Paragon 28, Inc.
P10-910-TB5R
In Commercial Distribution

  • 00889795062116 ()
P10-910-TB5R

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062109

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 5, Left
Paragon 28, Inc.
P10-910-TB5L
In Commercial Distribution

  • 00889795062109 ()
P10-910-TB5L

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062093

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 4, Right
Paragon 28, Inc.
P10-910-TB4R
In Commercial Distribution

  • 00889795062093 ()
P10-910-TB4R

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062086

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 4, Left
Paragon 28, Inc.
P10-910-TB4L
In Commercial Distribution

  • 00889795062086 ()
P10-910-TB4L

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062079

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 3, Right
Paragon 28, Inc.
P10-910-TB3R
In Commercial Distribution

  • 00889795062079 ()
P10-910-TB3R

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062062

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 3, Left
Paragon 28, Inc.
P10-910-TB3L
In Commercial Distribution

  • 00889795062062 ()
P10-910-TB3L

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062055

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 2, Right
Paragon 28, Inc.
P10-910-TB2R
In Commercial Distribution

  • 00889795062055 ()
P10-910-TB2R

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062048

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 2, Left
Paragon 28, Inc.
P10-910-TB2L
In Commercial Distribution

  • 00889795062048 ()
P10-910-TB2L

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062031

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 1, Right
Paragon 28, Inc.
P10-910-TB1R
In Commercial Distribution

  • 00889795062031 ()
P10-910-TB1R

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062024

APEX 3D-PS Total Ankle Replacement System, Trial Tibia, ARC, Size 1, Left
Paragon 28, Inc.
P10-910-TB1L
In Commercial Distribution

  • 00889795062024 ()
P10-910-TB1L

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795062017

APEX 3D-PS Total Ankle Replacement System, 3.0 Pin, 316LVM, Fluted, 160mm
Paragon 28, Inc.
P10-902-3016
In Commercial Distribution

  • 00889795062017 ()
P10-902-3016

  • Orthopaedic bone wire

APEX 3D Total Ankle Replacement System - 00889795062000

APEX 3D-PS Total Ankle Replacement System, 3.0 Pin, 316LVM, Fluted, 100mm
Paragon 28, Inc.
P10-902-3010
In Commercial Distribution

  • 00889795062000 ()
P10-902-3010

  • Orthopaedic bone wire

APEX 3D Total Ankle Replacement System - 00889795061997

APEX 3D-PS Total Ankle Replacement System, 2.4 Shoulder-Thread Pin, 50mm Thread length
Paragon 28, Inc.
P10-902-2450
In Commercial Distribution

  • 00889795061997 ()
P10-902-2450

  • Orthopaedic bone wire

APEX 3D Total Ankle Replacement System - 00889795061973

APEX 3D-PS Total Ankle Replacement System, Tibial Rasp, ARC, Size 6
Paragon 28, Inc.
P10-901-RSP6
In Commercial Distribution

  • 00889795061973 ()
P10-901-RSP6

  • Bone file/rasp, manual, reusable

APEX 3D Total Ankle Replacement System - 00889795061966

APEX 3D-PS Total Ankle Replacement System, Tibial Rasp, ARC, Size 5
Paragon 28, Inc.
P10-901-RSP5
In Commercial Distribution

  • 00889795061966 ()
P10-901-RSP5

  • Bone file/rasp, manual, reusable

APEX 3D Total Ankle Replacement System - 00889795061935

APEX 3D-PS Total Ankle Replacement System, Tibial Rasp, ARC, Size 2
Paragon 28, Inc.
P10-901-RSP2
In Commercial Distribution

  • 00889795061935 ()
P10-901-RSP2

  • Bone file/rasp, manual, reusable

APEX 3D Total Ankle Replacement System - 00889795061928

APEX 3D-PS Total Ankle Replacement System, Tibial Rasp, ARC, Size 1
Paragon 28, Inc.
P10-901-RSP1
In Commercial Distribution

  • 00889795061928 ()
P10-901-RSP1

  • Bone file/rasp, manual, reusable

APEX 3D Total Ankle Replacement System - 00889795061843

APEX 3D-PS Total Ankle Replacement System, T-Handle
Paragon 28, Inc.
P10-901-24TH
In Commercial Distribution

  • 00889795061843 ()
P10-901-24TH

  • Surgical instrument handle, non-torque-limiting

Phantom Hindfoot TTC/TC Nail System - 00889795061812

Phantom TTC Nail, 13.0 X 200mm, RIGHT
Paragon 28, Inc.
P31-330-200R-S
In Commercial Distribution

  • 00889795061812 ()
P31-330-200R-S

  • Arthrodesis intramedullary nail, non-distracting

Monster Screw System - 00889795016447

Monster BITE, Driver, AO
Paragon 28, Inc.
P24-905-0001
In Commercial Distribution

  • 00889795016447 ()
P24-905-0001

  • Surgical screwdriver, reusable

Monster Screw System - 00889795016423

Monster BITE Caddy, Insert
Paragon 28, Inc.
P24-900-BITE-2
In Commercial Distribution

  • 00889795016423 ()
P24-900-BITE-2

  • Device sterilization/disinfection container, reusable

Monster Screw System - 00889795016416

Monster BITE Caddy, Base
Paragon 28, Inc.
P24-900-BITE-1
In Commercial Distribution

  • 00889795016416 ()
P24-900-BITE-1

  • Device sterilization/disinfection container, reusable

Monster Screw System - 00889795016409

7.0 mm Monster Screw Tap
Paragon 28, Inc.
P20-920-7000
In Commercial Distribution

  • 00889795016409 ()
P20-920-7000

  • Bone tap, reusable

Monster Screw System - 00889795016386

4.5 mm Monster Screw Tap
Paragon 28, Inc.
P20-920-4500
In Commercial Distribution

  • 00889795016386 ()
P20-920-4500

  • Bone tap, reusable

Monster Screw System - 00889795016379

4.0mm Mini Monster Tap
Paragon 28, Inc.
P20-920-4000
In Commercial Distribution

  • 00889795016379 ()
P20-920-4000

  • Bone tap, reusable

Monster Screw System - 00889795016355

3.0mm Mini Monster Tap
Paragon 28, Inc.
P20-920-3000
In Commercial Distribution

  • 00889795016355 ()
P20-920-3000

  • Bone tap, reusable

Monster Screw System - 00889795016348

2.5mm Mini Monster Tap
Paragon 28, Inc.
P20-920-2500
In Commercial Distribution

  • 00889795016348 ()
P20-920-2500

  • Bone tap, reusable

Monster Screw System - 00889795016331

Case Tray Mini Monster Full DIN
Paragon 28, Inc.
P20-900-0032
In Commercial Distribution

  • 00889795016331 ()
P20-900-0032

  • Device sterilization/disinfection container, reusable

Monster Screw System - 00889795016317

Monster 5.5mm Combination Headed and Headless Caddy
Paragon 28, Inc.
P20-900-0022
In Commercial Distribution

  • 00889795016317 ()
P20-900-0022

  • Device sterilization/disinfection container, reusable

Monster Screw System - 00889795016300

Monster 4.5mm Combination Headed and Headless Caddye
Paragon 28, Inc.
P20-900-0021
In Commercial Distribution

  • 00889795016300 ()
P20-900-0021

  • Device sterilization/disinfection container, reusable

Monster Screw System - 00889795016294

Case Lid, Mini Monster
Paragon 28, Inc.
P20-900-0019
In Commercial Distribution

  • 00889795016294 ()
P20-900-0019

  • Device sterilization/disinfection container, reusable

Monster Screw System - 00889795016287

Case Base, Mini Monster
Paragon 28, Inc.
P20-900-0018
In Commercial Distribution

  • 00889795016287 ()
P20-900-0018

  • Device sterilization/disinfection container, reusable
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