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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 - 00889795111067

Laser Alignment Guide
Paragon 28, Inc.
P10-941-LAZM
In Commercial Distribution

  • 00889795111067 ()
P10-941-LAZM

  • Orthopaedic fixation implant alignment tool

Lesser Metatarsal Shortening System - 00889795111029

Saw Blade 9 x 31 x .051mm Stryker (Sterile)
Paragon 28, Inc.
P99-151-P30S-1-S
In Commercial Distribution

  • 00889795111029 ()
P99-151-P30S-1-S

  • Surgical saw blade, oscillating, single-use

Lesser Metatarsal Shortening System - 00889795111012

Saw Blade 9 x 31 x .051mm, MicroAire (Sterile)
Paragon 28, Inc.
P99-151-P30M-1-S
In Commercial Distribution

  • 00889795111012 ()
P99-151-P30M-1-S

  • Surgical saw blade, oscillating, single-use

MgNum - 00889795111005

MgNum, Bone Void Filler, Mixing and Delivery System
Paragon 28, Inc.
P02-BVF-AUX1
In Commercial Distribution

  • 00889795111005 ()
P02-BVF-AUX1

  • Bone graft delivery kit

MgNum - 00889795110992

MgNum, Bone Void Filler, 15cc
Paragon 28, Inc.
P02-BVF-0015
In Commercial Distribution

  • 00889795110992 ()
P02-BVF-0015

  • Bone matrix implant, synthetic, non-antimicrobial

MgNum - 00889795110985

MgNum, Bone Void Filler, 10cc
Paragon 28, Inc.
P02-BVF-0010
In Commercial Distribution

  • 00889795110985 ()
P02-BVF-0010

  • Bone matrix implant, synthetic, non-antimicrobial

MgNum - 00889795110978

MgNum, Bone Void Filler, 5cc
Paragon 28, Inc.
P02-BVF-0005
In Commercial Distribution

  • 00889795110978 ()
P02-BVF-0005

  • Bone matrix implant, synthetic, non-antimicrobial

APEX 3D Total Ankle Replacement System - 00889795110961

HEX SCREW DRIVER, SHORT, 3.5mm X 155mm
Paragon 28, Inc.
P99-150-HX35-SHORT
In Commercial Distribution

  • 00889795110961 ()
P99-150-HX35-SHORT

  • Surgical screwdriver, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110954

Screw Retention Sleeve
Paragon 28, Inc.
P99-191-SL10
In Commercial Distribution

  • 00889795110954 ()
P99-191-SL10

  • Orthopaedic implantation sleeve, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110947

Gorilla, Ankle Fx, Threaded Positioning Tower, LONG
Paragon 28, Inc.
P51-900-2002
In Commercial Distribution

  • 00889795110947 ()
P51-900-2002

  • Surgical drill guide, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110930

Ø3.5 x 13cm Solid Over Drill
Paragon 28, Inc.
P99-100-3513
In Commercial Distribution

  • 00889795110930 ()
P99-100-3513

  • Cannulated surgical drill bit, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110923

Ø2.0 x 14cm Solid Drill
Paragon 28, Inc.
P99-100-2013
In Commercial Distribution

  • 00889795110923 ()
P99-100-2013

  • Cannulated surgical drill bit, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110916

Ø4.2 Gorilla Tap
Paragon 28, Inc.
P51-911-4200
In Commercial Distribution

  • 00889795110916 ()
P51-911-4200

  • Bone tap, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110909

Ø3.5 Gorilla Tap
Paragon 28, Inc.
P51-911-3500
In Commercial Distribution

  • 00889795110909 ()
P51-911-3500

  • Bone tap, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110893

Ø2.7 Gorilla Tap
Paragon 28, Inc.
P51-911-2700
In Commercial Distribution

  • 00889795110893 ()
P51-911-2700

  • Bone tap, reusable

APEX 3D Total Ankle Replacement System - 00889795110886

Saw Blade 8 x 90mm, 1.27mm, Stryker
Paragon 28, Inc.
P99-151-P106-S
In Commercial Distribution

  • 00889795110886 ()
P99-151-P106-S

  • Surgical saw blade, sagittal, single-use

APEX 3D Total Ankle Replacement System - 00889795110862

Saw Blade 13 x 90mm, 1.27mm, Stryker
Paragon 28, Inc.
P99-151-P104-S
In Commercial Distribution

  • 00889795110862 ()
P99-151-P104-S

  • Surgical saw blade, sagittal, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795110824

Proximal Arm Assembly
Paragon 28, Inc.
P31-950-0035
In Commercial Distribution

  • 00889795110824 ()
P31-950-0035

  • Orthopaedic implantation sleeve, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110817

R3CON Non-Locking Screw, Ø3.50 x 100mm
Paragon 28, Inc.
P50-453-3500
In Commercial Distribution

  • 00889795110817 ()
P50-453-3500

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

APEX 3D Total Ankle Replacement System - 00889795110695

TOTAL ANKLE, INSTRUMENT, CHAMFER CHECKER, AP DOUBLE-ENDED, V2.0
Paragon 28, Inc.
P10-944-TCC4
In Commercial Distribution

  • 00889795110695 ()
P10-944-TCC4

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110688

TOTAL ANKLE, INSTRUMENT, CHAMFER CHECKER, ALL-IN-ONE, V2.0
Paragon 28, Inc.
P10-944-TCC3
In Commercial Distribution

  • 00889795110688 ()
P10-944-TCC3

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110671

Total Ankle Replacement System, Poly Trial Insert, Size 5, 20mm
Paragon 28, Inc.
P10-930-I520
In Commercial Distribution

  • 00889795110671 ()
P10-930-I520

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110664

Total Ankle Replacement System, Poly Trial Insert, Size 5, 18mm
Paragon 28, Inc.
P10-930-I518
In Commercial Distribution

  • 00889795110664 ()
P10-930-I518

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110657

Total Ankle Replacement System, Poly Trial Insert, Size 5, 16mm
Paragon 28, Inc.
P10-930-I516
In Commercial Distribution

  • 00889795110657 ()
P10-930-I516

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110640

Total Ankle Replacement System, Poly Trial Insert, Size 5, 14mm
Paragon 28, Inc.
P10-930-I514
In Commercial Distribution

  • 00889795110640 ()
P10-930-I514

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110633

Total Ankle Replacement System, Poly Trial Insert, Size 4, 20mm
Paragon 28, Inc.
P10-930-I420
In Commercial Distribution

  • 00889795110633 ()
P10-930-I420

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110626

Total Ankle Replacement System, Poly Trial Insert, Size 4, 18mm
Paragon 28, Inc.
P10-930-I418
In Commercial Distribution

  • 00889795110626 ()
P10-930-I418

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110619

Total Ankle Replacement System, Poly Trial Insert, Size 4, 16mm
Paragon 28, Inc.
P10-930-I416
In Commercial Distribution

  • 00889795110619 ()
P10-930-I416

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110602

Total Ankle Replacement System, Poly Trial Insert, Size 4, 14mm
Paragon 28, Inc.
P10-930-I414
In Commercial Distribution

  • 00889795110602 ()
P10-930-I414

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110596

Total Ankle Replacement System, Poly Trial Insert, Size 3, 20mm
Paragon 28, Inc.
P10-930-I320
In Commercial Distribution

  • 00889795110596 ()
P10-930-I320

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110589

Total Ankle Replacement System, Poly Trial Insert, Size 3, 18mm
Paragon 28, Inc.
P10-930-I318
In Commercial Distribution

  • 00889795110589 ()
P10-930-I318

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110572

Total Ankle Replacement System, Poly Trial Insert, Size 3, 16mm
Paragon 28, Inc.
P10-930-I316
In Commercial Distribution

  • 00889795110572 ()
P10-930-I316

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110565

Total Ankle Replacement System, Poly Trial Insert, Size 3, 14mm
Paragon 28, Inc.
P10-930-I314
In Commercial Distribution

  • 00889795110565 ()
P10-930-I314

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110558

Total Ankle Replacement System, Poly Trial Insert, Size 2, 20mm
Paragon 28, Inc.
P10-930-I220
In Commercial Distribution

  • 00889795110558 ()
P10-930-I220

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110541

Total Ankle Replacement System, Poly Trial Insert, Size 2, 18mm
Paragon 28, Inc.
P10-930-I218
In Commercial Distribution

  • 00889795110541 ()
P10-930-I218

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110534

Total Ankle Replacement System, Poly Trial Insert, Size 2, 16mm
Paragon 28, Inc.
P10-930-I216
In Commercial Distribution

  • 00889795110534 ()
P10-930-I216

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110527

Total Ankle Replacement System, Poly Trial Insert, Size 2, 14mm
Paragon 28, Inc.
P10-930-I214
In Commercial Distribution

  • 00889795110527 ()
P10-930-I214

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110510

Total Ankle Replacement System, Poly Trial Insert, Size 1, 20mm
Paragon 28, Inc.
P10-930-I120
In Commercial Distribution

  • 00889795110510 ()
P10-930-I120

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110503

Total Ankle Replacement System, Poly Trial Insert, Size 1, 18mm
Paragon 28, Inc.
P10-930-I118
In Commercial Distribution

  • 00889795110503 ()
P10-930-I118

  • Surgical implant template, reusable

APEX 3D Total Ankle Replacement System - 00889795110497

Total Ankle Replacement System, Poly Trial Insert, Size 1, 16mm
Paragon 28, Inc.
P10-930-I116
In Commercial Distribution

  • 00889795110497 ()
P10-930-I116

  • Surgical implant template, reusable
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