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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 - 00889795117519

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 7MM, 3.5MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I307-S
In Commercial Distribution

  • 00889795117519 ()
P10-31A-I307-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117502

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 6MM, 3.5MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I306-S
In Commercial Distribution

  • 00889795117502 ()
P10-31A-I306-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117496

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 10MM, 3.25MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I210-S
In Commercial Distribution

  • 00889795117496 ()
P10-31A-I210-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117489

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 9MM, 3.25MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I209-S
In Commercial Distribution

  • 00889795117489 ()
P10-31A-I209-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117472

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 8MM, 3.25MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I208-S
In Commercial Distribution

  • 00889795117472 ()
P10-31A-I208-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117465

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 7MM, 3.25MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I207-S
In Commercial Distribution

  • 00889795117465 ()
P10-31A-I207-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117458

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 6MM, 3.25MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I206-S
In Commercial Distribution

  • 00889795117458 ()
P10-31A-I206-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117441

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 10MM, 3MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I110-S
In Commercial Distribution

  • 00889795117441 ()
P10-31A-I110-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117434

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 9MM, 3MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I109-S
In Commercial Distribution

  • 00889795117434 ()
P10-31A-I109-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117427

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 8MM, 3MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I108-S
In Commercial Distribution

  • 00889795117427 ()
P10-31A-I108-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117410

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 7MM, 3MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I107-S
In Commercial Distribution

  • 00889795117410 ()
P10-31A-I107-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795117403

APEX 3D™ Cross-linked Vitamin E POLY, SIZE 1 x 6MM, 3MM ANT OFFSET
Paragon 28, Inc.
P10-31A-I106-S
In Commercial Distribution

  • 00889795117403 ()
P10-31A-I106-S

  • Fixed-bearing total ankle prosthesis

Phantom Hindfoot TTC/TC Nail System - 00889795117397

Phantom 7.2 countersink
Paragon 28, Inc.
P31-915-7200
In Commercial Distribution

  • 00889795117397 ()
P31-915-7200

  • Surgical countersink, reusable

APEX 3D Total Ankle Replacement System - 00889795117380

APEX 3D-PS TAR, Poly Trial Insert, Size 5, 10mm, 4.00MM ANT/POST OFFSET
Paragon 28, Inc.
P10-931-I510
In Commercial Distribution

  • 00889795117380 ()
P10-931-I510

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795117373

APEX 3D-PS TAR, Poly Trial Insert, Size 5, 9mm, 4.00MM ANT/POST OFFSET
Paragon 28, Inc.
P10-931-I509
In Commercial Distribution

  • 00889795117373 ()
P10-931-I509

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795117366

APEX 3D-PS TAR, Poly Trial Insert, Size 5, 8mm, 4.00MM ANT/POST OFFSET
Paragon 28, Inc.
P10-931-I508
In Commercial Distribution

  • 00889795117366 ()
P10-931-I508

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795117359

APEX 3D-PS TAR, Poly Trial Insert, Size 5, 7mm, 4.00MM ANT/POST OFFSET
Paragon 28, Inc.
P10-931-I507
In Commercial Distribution

  • 00889795117359 ()
P10-931-I507

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795117342

APEX 3D-PS TAR, Poly Trial Insert, Size 5, 6mm, 4.00MM ANT/POST OFFSET
Paragon 28, Inc.
P10-931-I506
In Commercial Distribution

  • 00889795117342 ()
P10-931-I506

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795117335

APEX 3D-PS TAR, Poly Trial Insert, Size 4, 10mm, 3.75MM ANT/POST OFFSET
Paragon 28, Inc.
P10-931-I410
In Commercial Distribution

  • 00889795117335 ()
P10-931-I410

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795117328

APEX 3D-PS TAR, Poly Trial Insert, Size 4, 9mm, 3.75MM ANT/POST OFFSET
Paragon 28, Inc.
P10-931-I409
In Commercial Distribution

  • 00889795117328 ()
P10-931-I409

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795117311

APEX 3D-PS TAR, Poly Trial Insert, Size 4, 8mm, 3.75MM ANT/POST OFFSET
Paragon 28, Inc.
P10-931-I408
In Commercial Distribution

  • 00889795117311 ()
P10-931-I408

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795117304

APEX 3D-PS TAR, Poly Trial Insert, Size 4, 7mm, 3.75MM ANT/POST OFFSET
Paragon 28, Inc.
P10-931-I407
In Commercial Distribution

  • 00889795117304 ()
P10-931-I407

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795117298

APEX 3D-PS TAR, Poly Trial Insert, Size 4, 6mm, 3.75MM ANT/POST OFFSET
Paragon 28, Inc.
P10-931-I406
In Commercial Distribution

  • 00889795117298 ()
P10-931-I406

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795117281

APEX 3D-PS TAR, Poly Trial Insert, Size 3, 10mm, 3.50MM ANT/POST OFFSET
Paragon 28, Inc.
P10-931-I310
In Commercial Distribution

  • 00889795117281 ()
P10-931-I310

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795117274

APEX 3D-PS TAR, Poly Trial Insert, Size 3, 9mm, 3.50MM ANT/POST OFFSET
Paragon 28, Inc.
P10-931-I309
In Commercial Distribution

  • 00889795117274 ()
P10-931-I309

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795117267

APEX 3D-PS TAR, Poly Trial Insert, Size 3, 8mm, 3.50MM ANT/POST OFFSET
Paragon 28, Inc.
P10-931-I308
In Commercial Distribution

  • 00889795117267 ()
P10-931-I308

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795117250

APEX 3D-PS TAR, Poly Trial Insert, Size 3, 7mm, 3.50MM ANT/POST OFFSET
Paragon 28, Inc.
P10-931-I307
In Commercial Distribution

  • 00889795117250 ()
P10-931-I307

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795117243

APEX 3D-PS TAR, Poly Trial Insert, Size 3, 6mm, 3.50MM ANT/POST OFFSET
Paragon 28, Inc.
P10-931-I306
In Commercial Distribution

  • 00889795117243 ()
P10-931-I306

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795117236

APEX 3D-PS TAR, Poly Trial Insert, Size 2, 10mm, 3.25MM ANT/POST OFFSET
Paragon 28, Inc.
P10-931-I210
In Commercial Distribution

  • 00889795117236 ()
P10-931-I210

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795117229

APEX 3D-PS TAR, Poly Trial Insert, Size 2, 9mm, 3.25MM ANT/POST OFFSET
Paragon 28, Inc.
P10-931-I209
In Commercial Distribution

  • 00889795117229 ()
P10-931-I209

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795117212

APEX 3D-PS TAR, Poly Trial Insert, Size 2, 8mm, 3.25MM ANT/POST OFFSET
Paragon 28, Inc.
P10-931-I208
In Commercial Distribution

  • 00889795117212 ()
P10-931-I208

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795117205

APEX 3D-PS TAR, Poly Trial Insert, Size 2, 7mm, 3.25MM ANT/POST OFFSET
Paragon 28, Inc.
P10-931-I207
In Commercial Distribution

  • 00889795117205 ()
P10-931-I207

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795117199

APEX 3D-PS TAR, Poly Trial Insert, Size 2, 6mm, 3.25MM ANT/POST OFFSET
Paragon 28, Inc.
P10-931-I206
In Commercial Distribution

  • 00889795117199 ()
P10-931-I206

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795117182

APEX 3D-PS TAR, Poly Trial Insert, Size 1, 10mm, 3.00MM ANT/POST OFFSET
Paragon 28, Inc.
P10-931-I110
In Commercial Distribution

  • 00889795117182 ()
P10-931-I110

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795117175

APEX 3D-PS TAR, Poly Trial Insert, Size 1, 9mm, 3.00MM ANT/POST OFFSET
Paragon 28, Inc.
P10-931-I109
In Commercial Distribution

  • 00889795117175 ()
P10-931-I109

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795117168

APEX 3D-PS TAR, Poly Trial Insert, Size 1, 8mm, 3.00MM ANT/POST OFFSET
Paragon 28, Inc.
P10-931-I108
In Commercial Distribution

  • 00889795117168 ()
P10-931-I108

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795117151

APEX 3D-PS TAR, Poly Trial Insert, Size 1, 7mm, 3.00MM ANT/POST OFFSET
Paragon 28, Inc.
P10-931-I107
In Commercial Distribution

  • 00889795117151 ()
P10-931-I107

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795117144

APEX 3D-PS TAR, Poly Trial Insert, Size 1, 6mm, 3.00MM ANT/POST OFFSET
Paragon 28, Inc.
P10-931-I106
In Commercial Distribution

  • 00889795117144 ()
P10-931-I106

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795116642

Total Ankle, Instrument, Poly Trial Insert, Size 3, 12MM, 3.50MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I312
In Commercial Distribution

  • 00889795116642 ()
P10-931-I312

  • Surgical implant template, reusable

Monkey Rings™ External Fixation System - 00889795116611

Protective Cap, 6.0
Paragon 28, Inc.
P45-198-6000
In Commercial Distribution

  • 00889795116611 ()
P45-198-6000

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795116604

Protective Cap, 5.0
Paragon 28, Inc.
P45-198-5000
In Commercial Distribution

  • 00889795116604 ()
P45-198-5000

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795116598

Protective Cap, 4.0
Paragon 28, Inc.
P45-198-4000
In Commercial Distribution

  • 00889795116598 ()
P45-198-4000

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795116581

Foot Rocker Kit
Paragon 28, Inc.
P45-170-1000
In Commercial Distribution

  • 00889795116581 ()
P45-170-1000

  • Orthopaedic fixation implant alignment tool

Monkey Rings™ External Fixation System - 00889795116574

Monkey Rings, Case 4, Tray 2
Paragon 28, Inc.
P45-904-TRY2
In Commercial Distribution

  • 00889795116574 ()
P45-904-TRY2

  • Device sterilization/disinfection container, reusable

Monkey Rings™ External Fixation System - 00889795116567

Tray 1, Case 4 of 5
Paragon 28, Inc.
P45-904-TRY1
In Commercial Distribution

  • 00889795116567 ()
P45-904-TRY1

  • Device sterilization/disinfection container, reusable

Monkey Rings™ External Fixation System - 00889795116550

Case Base, Case 4 of 5
Paragon 28, Inc.
P45-904-BASE
In Commercial Distribution

  • 00889795116550 ()
P45-904-BASE

  • Device sterilization/disinfection container, reusable

Monkey Rings™ External Fixation System - 00889795116505

Pin Cutter
Paragon 28, Inc.
P45-520-2000
In Commercial Distribution

  • 00889795116505 ()
P45-520-2000

  • Orthopaedic implantable-device cutter

Monkey Rings™ External Fixation System - 00889795116482

Hex Driver on T Handle
Paragon 28, Inc.
P45-515-0001
In Commercial Distribution

  • 00889795116482 ()
P45-515-0001

  • Surgical screwdriver, reusable

Monkey Rings™ External Fixation System - 00889795116475

ARTICULATING WRENCH
Paragon 28, Inc.
P45-514-0001
In Commercial Distribution

  • 00889795116475 ()
P45-514-0001

  • Orthopaedic fixation implant alignment tool

Monkey Rings External Fixation System - 00889795116468

Ratchet Wrench, 10mm (OIC wrench)
Paragon 28, Inc.
P45-513-0010
In Commercial Distribution

  • 00889795116468 ()
P45-513-0010

  • Surgical torque wrench, reusable
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