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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 - 00889795121561

Total Ankle, Instrument, Poly Trial Insert, Size 4, 18MM, 3.75MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I418
In Commercial Distribution

  • 00889795121561 ()
P10-931-I418

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795121554

Total Ankle, Instrument, Poly Trial Insert, Size 4, 17MM, 3.75MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I417
In Commercial Distribution

  • 00889795121554 ()
P10-931-I417

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795121547

Total Ankle, Instrument, Poly Trial Insert, Size 4, 16MM, 3.75MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I416
In Commercial Distribution

  • 00889795121547 ()
P10-931-I416

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795121530

Total Ankle, Instrument, Poly Trial Insert, Size 4, 15MM, 3.75MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I415
In Commercial Distribution

  • 00889795121530 ()
P10-931-I415

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795121523

Total Ankle, Instrument, Poly Trial Insert, Size 4, 14MM, 3.75MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I414
In Commercial Distribution

  • 00889795121523 ()
P10-931-I414

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795121516

Total Ankle, Instrument, Poly Trial Insert, Size 4, 13MM, 3.75MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I413
In Commercial Distribution

  • 00889795121516 ()
P10-931-I413

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795121509

Total Ankle, Instrument, Poly Trial Insert, Size 4, 12MM, 3.75MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I412
In Commercial Distribution

  • 00889795121509 ()
P10-931-I412

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795121493

Total Ankle, Instrument, Poly Trial Insert, Size 4, 11MM, 3.75MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I411
In Commercial Distribution

  • 00889795121493 ()
P10-931-I411

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795121486

Total Ankle, Instrument, Poly Trial Insert, Size 3, 20MM, 3.50MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I320
In Commercial Distribution

  • 00889795121486 ()
P10-931-I320

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795121479

Total Ankle, Instrument, Poly Trial Insert, Size 3, 19MM, 3.50MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I319
In Commercial Distribution

  • 00889795121479 ()
P10-931-I319

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795121462

Total Ankle, Instrument, Poly Trial Insert, Size 3, 18MM, 3.50MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I318
In Commercial Distribution

  • 00889795121462 ()
P10-931-I318

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795121455

Total Ankle, Instrument, Poly Trial Insert, Size 3, 17MM, 3.50MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I317
In Commercial Distribution

  • 00889795121455 ()
P10-931-I317

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795121448

APEX 3D-PS Total Ankle Replacement System, Talus Impaction Handle, Screw
Paragon 28, Inc.
P10-952-TL00-05
In Commercial Distribution

  • 00889795121448 ()
P10-952-TL00-05

  • Surgical instrument handle, non-torque-limiting

Monkey Rings™ External Fixation System - 00889795121431

Rapid Nut Allen Wrench
Paragon 28, Inc.
P45-517-0001
In Commercial Distribution

  • 00889795121431 ()
P45-517-0001

  • Surgical torque wrench, reusable

APEX 3D Total Ankle Replacement System - 00889795121424

Total Ankle, Instrument, Poly Trial Insert, Size 3, 16MM, 3.50MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I316
In Commercial Distribution

  • 00889795121424 ()
P10-931-I316

  • Surgical implant template, reusable

Grappler™ Suture Anchor System - 00889795121417

K-Wire with depth markings, 3.2mm 15cm
Paragon 28, Inc.
P44-943-3215
In Commercial Distribution

  • 00889795121417 ()
P44-943-3215

  • Orthopaedic bone wire

Paragon 28 Bone Wedge System - 00889795121400

Additive Orthopaedics General Trial Caddy Lid
Paragon 28, Inc.
AOTRL-01-02
In Commercial Distribution

  • 00889795121400 ()
AOTRL-01-02

  • Device sterilization/disinfection container, reusable

Paragon 28 Bone Wedge System - 00889795121394

Additive Orthopaedics General Trial Caddy Base
Paragon 28, Inc.
AOTRL-01-01
In Commercial Distribution

  • 00889795121394 ()
AOTRL-01-01

  • Device sterilization/disinfection container, reusable

Paragon 28 Bone Wedge System - 00889795121387

Additive Orthopaedics Cotton Wedge Trial, 20-8
Paragon 28, Inc.
AOCW-20-8 TRL
In Commercial Distribution

  • 00889795121387 ()
AOCW-20-8 TRL

  • Surgical implant/trial-implant/sizer holder, reusable

Paragon 28 Bone Wedge System - 00889795121370

Additive Orthopaedics Cotton Wedge Trial, 18-8
Paragon 28, Inc.
AOCW-18-8 TRL
In Commercial Distribution

  • 00889795121370 ()
AOCW-18-8 TRL

  • Surgical implant/trial-implant/sizer holder, reusable

Paragon 28 Bone Wedge System - 00889795121363

Additive Orthopaedics Cotton Wedge Trial, 16-8
Paragon 28, Inc.
AOCW-16-8 TRL
In Commercial Distribution

  • 00889795121363 ()
AOCW-16-8 TRL

  • Surgical implant/trial-implant/sizer holder, reusable

Paragon 28 Bone Wedge System - 00889795121356

Additive Orthopaedics Cotton Wedge Trial, 20-10
Paragon 28, Inc.
AOCW-20-10 TRL
In Commercial Distribution

  • 00889795121356 ()
AOCW-20-10 TRL

  • Surgical implant/trial-implant/sizer holder, reusable

Paragon 28 Bone Wedge System - 00889795121349

Additive Orthopaedics Cotton Wedge Trial, 18-10
Paragon 28, Inc.
AOCW-18-10 TRL
In Commercial Distribution

  • 00889795121349 ()
AOCW-18-10 TRL

  • Surgical implant/trial-implant/sizer holder, reusable

Paragon 28 Bone Wedge System - 00889795121332

Additive Orthopaedics Cotton Wedge Trial, 16-10
Paragon 28, Inc.
AOCW-16-10 TRL
In Commercial Distribution

  • 00889795121332 ()
AOCW-16-10 TRL

  • Surgical implant/trial-implant/sizer holder, reusable

APEX 3D Total Ankle Replacement System - 00889795121325

Total Ankle, Instrument, Poly Trial Insert, Size 3, 15MM, 3.50MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I315
In Commercial Distribution

  • 00889795121325 ()
P10-931-I315

  • Surgical implant template, reusable

Paragon 28 Bone Wedge System - 00889795121301

Additive Orthopaedics Organic Cotton Wedge Trial, 20-8
Paragon 28, Inc.
AOCWO-20-8 TRL
In Commercial Distribution

  • 00889795121301 ()
AOCWO-20-8 TRL

  • Surgical implant/trial-implant/sizer holder, reusable

Paragon 28 Bone Wedge System - 00889795121295

Additive Orthopaedics Organic Cotton Wedge Trial, 20-7
Paragon 28, Inc.
AOCWO-20-7 TRL
In Commercial Distribution

  • 00889795121295 ()
AOCWO-20-7 TRL

  • Surgical implant/trial-implant/sizer holder, reusable

Paragon 28 Bone Wedge System - 00889795121288

Additive Orthopaedics Organic Cotton Wedge Trial, 20-6
Paragon 28, Inc.
AOCWO-20-6 TRL
In Commercial Distribution

  • 00889795121288 ()
AOCWO-20-6 TRL

  • Surgical implant/trial-implant/sizer holder, reusable

Paragon 28 Bone Wedge System - 00889795121271

Additive Orthopaedics Organic Cotton Wedge Trial, 20-5
Paragon 28, Inc.
AOCWO-20-5 TRL
In Commercial Distribution

  • 00889795121271 ()
AOCWO-20-5 TRL

  • Surgical implant/trial-implant/sizer holder, reusable

APEX 3D Total Ankle Replacement System - 00889795121264

Total Ankle, Instrument, Poly Trial Insert, Size 3, 14MM, 3.50MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I314
In Commercial Distribution

  • 00889795121264 ()
P10-931-I314

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795121202

Total Ankle, Instrument, Poly Trial Insert, Size 3, 13MM, 3.50MM ANT/POST Offset, PPSU
Paragon 28, Inc.
P10-931-I313
In Commercial Distribution

  • 00889795121202 ()
P10-931-I313

  • Surgical implant template, reusable

Paragon 28 Bone Wedge System - 00889795121189

Additive Orthopaedics Organic Cotton Wedge Trial, 16-8
Paragon 28, Inc.
AOCWO-16-8 TRL
In Commercial Distribution

  • 00889795121189 ()
AOCWO-16-8 TRL

  • Surgical implant/trial-implant/sizer holder, reusable

Paragon 28 Bone Wedge System - 00889795121172

Additive Orthopaedics Organic Cotton Wedge Trial, 16-7
Paragon 28, Inc.
AOCWO-16-7 TRL
In Commercial Distribution

  • 00889795121172 ()
AOCWO-16-7 TRL

  • Surgical implant/trial-implant/sizer holder, reusable

Paragon 28 Bone Wedge System - 00889795121165

Additive Orthopaedics Organic Cotton Wedge Trial, 16-6
Paragon 28, Inc.
AOCWO-16-6 TRL
In Commercial Distribution

  • 00889795121165 ()
AOCWO-16-6 TRL

  • Surgical implant/trial-implant/sizer holder, reusable

Paragon 28 Bone Wedge System - 00889795121158

Additive Orthopaedics Organic Cotton Wedge Trial, 16-5
Paragon 28, Inc.
AOCWO-16-5 TRL
In Commercial Distribution

  • 00889795121158 ()
AOCWO-16-5 TRL

  • Surgical implant/trial-implant/sizer holder, reusable

Monster Screw System - 00889795120984

K-wire, Single Ended Trocar Tip, SMOOTH, 2.6 x 150mm
Paragon 28, Inc.
P99-192-2615
In Commercial Distribution

  • 00889795120984 ()
P99-192-2615

  • Orthopaedic bone wire

Monkey Rings™ External Fixation System - 00889795120977

Case 3 Fasterner Caddy
Paragon 28, Inc.
P45-903-CAD2
In Commercial Distribution

  • 00889795120977 ()
P45-903-CAD2

  • Device sterilization/disinfection container, reusable

Monkey Rings™ External Fixation System - 00889795120960

Case 3 K-Wire Caddy
Paragon 28, Inc.
P45-903-CAD1
In Commercial Distribution

  • 00889795120960 ()
P45-903-CAD1

  • Device sterilization/disinfection container, reusable

Monkey Rings™ External Fixation System - 00889795120953

Tubular Wrench, 10mm
Paragon 28, Inc.
P45-513-0004
In Commercial Distribution

  • 00889795120953 ()
P45-513-0004

  • Surgical torque wrench, reusable

APEX 3D Total Ankle Replacement System - 00889795120946

APEX 3D Total Ankle, Instrument, Tibia Impaction Protector, Size 5-6
Paragon 28, Inc.
P10-851-TP56
In Commercial Distribution

  • 00889795120946 ()
P10-851-TP56

  • Orthopaedic implant impactor, reusable

APEX 3D Total Ankle Replacement System - 00889795120939

APEX 3D Total Ankle, Instrument, Tibia Impaction Protector, Size 3-4
Paragon 28, Inc.
P10-851-TP34
In Commercial Distribution

  • 00889795120939 ()
P10-851-TP34

  • Orthopaedic implant impactor, reusable

APEX 3D Total Ankle Replacement System - 00889795120922

APEX 3D Total Ankle, Instrument, Tibia Impaction Protector, Size 1-2
Paragon 28, Inc.
P10-851-TP12
In Commercial Distribution

  • 00889795120922 ()
P10-851-TP12

  • Orthopaedic implant impactor, reusable

Monkey Rings™ External Fixation System - 00889795120915

Case Base, Case 2 of 4
Paragon 28, Inc.
P45-902-BASE
In Commercial Distribution

  • 00889795120915 ()
P45-902-BASE

  • Device sterilization/disinfection container, reusable

Monkey Rings™ External Fixation System - 00889795120908

Case Dishwasher, Case 1 of 4
Paragon 28, Inc.
P45-901-DISH
In Commercial Distribution

  • 00889795120908 ()
P45-901-DISH

  • Device sterilization/disinfection container, reusable

Paragon 28 Bone Wedge System - 00889795120830

AO NON-LCKG SCW 3.0MM X 30MM
Paragon 28, Inc.
AONLS3030
In Commercial Distribution

  • 00889795120830 ()
AONLS3030

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Paragon 28 Bone Wedge System - 00889795120823

AO NON-LCKG SCW 3.0MM X 28MM
Paragon 28, Inc.
AONLS3028
In Commercial Distribution

  • 00889795120823 ()
AONLS3028

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Paragon 28 Bone Wedge System - 00889795120816

AO NON-LCKG SCW 3.0MM X 26MM
Paragon 28, Inc.
AONLS3026
In Commercial Distribution

  • 00889795120816 ()
AONLS3026

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Paragon 28 Bone Wedge System - 00889795120809

AO NON-LCKG SCW 3.0MM X 24MM
Paragon 28, Inc.
AONLS3024
In Commercial Distribution

  • 00889795120809 ()
AONLS3024

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Paragon 28 Bone Wedge System - 00889795120793

AO NON-LCKG SCW 3.0MM X 22MM
Paragon 28, Inc.
AONLS3022
In Commercial Distribution

  • 00889795120793 ()
AONLS3022

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Paragon 28 Bone Wedge System - 00889795120786

AO NON-LCKG SCW 3.0MM X 20MM
Paragon 28, Inc.
AONLS3020
In Commercial Distribution

  • 00889795120786 ()
AONLS3020

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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