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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 - 00889795143600

TOTAL ANKLE IMPLANT, INSERT, SIZE 2, 20 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I220-S
In Commercial Distribution

  • 00889795143600 ()
P10-310-I220-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143587

TOTAL ANKLE IMPLANT, INSERT, SIZE 2, 16 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I216-S
In Commercial Distribution

  • 00889795143587 ()
P10-310-I216-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143563

TOTAL ANKLE IMPLANT, INSERT, SIZE 2, 12 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I212-S
In Commercial Distribution

  • 00889795143563 ()
P10-310-I212-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143549

TOTAL ANKLE IMPLANT, INSERT, SIZE 2, 10 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I210-S
In Commercial Distribution

  • 00889795143549 ()
P10-310-I210-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143525

TOTAL ANKLE IMPLANT, INSERT, SIZE 2, 8 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I208-S
In Commercial Distribution

  • 00889795143525 ()
P10-310-I208-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143501

TOTAL ANKLE IMPLANT, INSERT, SIZE 2, 6 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I206-S
In Commercial Distribution

  • 00889795143501 ()
P10-310-I206-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143488

TOTAL ANKLE IMPLANT, INSERT, SIZE 1, 18 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I118-S
In Commercial Distribution

  • 00889795143488 ()
P10-310-I118-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143457

TOTAL ANKLE IMPLANT, INSERT, SIZE 1, 12 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I112-S
In Commercial Distribution

  • 00889795143457 ()
P10-310-I112-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143433

TOTAL ANKLE IMPLANT, INSERT, SIZE 1, 10 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I110-S
In Commercial Distribution

  • 00889795143433 ()
P10-310-I110-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143419

TOTAL ANKLE IMPLANT, INSERT, SIZE 1, 8 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I108-S
In Commercial Distribution

  • 00889795143419 ()
P10-310-I108-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143396

TOTAL ANKLE IMPLANT, INSERT, SIZE 1, 6 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I106-S
In Commercial Distribution

  • 00889795143396 ()
P10-310-I106-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143389

Talus, Flat, Right, Size 5, TPS
Paragon 28, Inc.
P10-251-TLR5-S
In Commercial Distribution

  • 00889795143389 ()
P10-251-TLR5-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143372

Talus, Flat, Right, Size 4, TPS
Paragon 28, Inc.
P10-251-TLR4-S
In Commercial Distribution

  • 00889795143372 ()
P10-251-TLR4-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143365

Talus, Flat, Right, Size 3, TPS
Paragon 28, Inc.
P10-251-TLR3-S
In Commercial Distribution

  • 00889795143365 ()
P10-251-TLR3-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143358

Talus, Flat, Right, Size 2, TPS
Paragon 28, Inc.
P10-251-TLR2-S
In Commercial Distribution

  • 00889795143358 ()
P10-251-TLR2-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143341

Talus, Flat, Right, Size 1, TPS
Paragon 28, Inc.
P10-251-TLR1-S
In Commercial Distribution

  • 00889795143341 ()
P10-251-TLR1-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143334

Talus, Flat, Right, Size 1 Narrow, TPS
Paragon 28, Inc.
P10-251-TLR0-S
In Commercial Distribution

  • 00889795143334 ()
P10-251-TLR0-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795143327

Talus, Flat, Left, Size 5, TPS
Paragon 28, Inc.
P10-251-TLL5-S
In Commercial Distribution

  • 00889795143327 ()
P10-251-TLL5-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795142887

Tibia, Arc, Right, Size 6, Standard, 3DP
Paragon 28, Inc.
P10-100-BR6S-S
In Commercial Distribution

  • 00889795142887 ()
P10-100-BR6S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795142870

Tibia, Arc, Right, Size 6, Long, 3DP
Paragon 28, Inc.
P10-100-BR6L-S
In Commercial Distribution

  • 00889795142870 ()
P10-100-BR6L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795142863

Tibia, Arc, Right, Size 5, Standard, 3DP
Paragon 28, Inc.
P10-100-BR5S-S
In Commercial Distribution

  • 00889795142863 ()
P10-100-BR5S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795142856

Tibia, Arc, Right, Size 5, Long, 3DP
Paragon 28, Inc.
P10-100-BR5L-S
In Commercial Distribution

  • 00889795142856 ()
P10-100-BR5L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795142849

Tibia, Arc, Right, Size 4, Standard, 3DP
Paragon 28, Inc.
P10-100-BR4S-S
In Commercial Distribution

  • 00889795142849 ()
P10-100-BR4S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795142832

Tibia, Arc, Right, Size 4, Long, 3DP
Paragon 28, Inc.
P10-100-BR4L-S
In Commercial Distribution

  • 00889795142832 ()
P10-100-BR4L-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795142825

Tibia, Arc, Right, Size 3, Standard, 3DP
Paragon 28, Inc.
P10-100-BR3S-S
In Commercial Distribution

  • 00889795142825 ()
P10-100-BR3S-S

  • Fixed-bearing total ankle prosthesis

Monkey Bars™ Pin to Bar External Fixation System - 00889795141569

175mm X 210mm Carbon Bar Kickstand
Paragon 28, Inc.
P85-410-128U
In Commercial Distribution

  • 00889795141569 ()
P85-410-128U

  • External orthopaedic fixation system, single-use

Grappler Interference Screw System - 00889795141521

1.6 X 20cm, Eyelet K-wire w/ Markings
Paragon 28, Inc.
P62-197-1620
In Commercial Distribution

  • 00889795141521 ()
P62-197-1620

  • Orthopaedic guidewire, single-use

Grappler Interference Screw System - 00889795141477

PCFD Tether, Talar Wire Guide
Paragon 28, Inc.
P62-910-0007
In Commercial Distribution

  • 00889795141477 ()
P62-910-0007

  • Surgical drill guide, reusable

Grappler Interference Screw System - 00889795141460

PCFD Tether, Sustentaculum Wire Guide
Paragon 28, Inc.
P62-910-0006
In Commercial Distribution

  • 00889795141460 ()
P62-910-0006

  • Surgical drill guide, reusable

Grappler Interference Screw System - 00889795141439

PCFD Tether, Targeting Guide Assembly
Paragon 28, Inc.
P62-910-0001
In Commercial Distribution

  • 00889795141439 ()
P62-910-0001

  • Surgical drill guide, reusable

APEX 3D Total Ankle Replacement System - 00889795141217

APEX 3D-PS Total Ankle Replacement System, Small Tray
Paragon 28, Inc.
P10-800-0007
In Commercial Distribution

  • 00889795141217 ()
P10-800-0007

  • Device sterilization/disinfection container, reusable

Monkey Bars™ Pin to Bar External Fixation System - 00889795140821

Ratcheting T-Handle, AO and 10mm Socket
Paragon 28, Inc.
P85-000-316T
In Commercial Distribution

  • 00889795140821 ()
P85-000-316T

  • Surgical instrument handle, non-torque-limiting

Monkey Bars™ Pin to Bar External Fixation System - 00889795140739

11mm Bar and 5mm Pin Combination Clamp
Paragon 28, Inc.
P85-310-1105
In Commercial Distribution

  • 00889795140739 ()
P85-310-1105

  • External orthopaedic fixation system, single-use

APEX 3D S Total Ankle Replacement System - 00889795140715

Short Stem Tibia System, Instrument Case, Lid
Paragon 28, Inc.
P11-900-CASL
In Commercial Distribution

  • 00889795140715 ()
P11-900-CASL

  • Device sterilization/disinfection container, reusable

APEX 3D S Total Ankle Replacement System - 00889795140708

Short Stem Tibia System, Instrument Case, Base
Paragon 28, Inc.
P11-900-CASB
In Commercial Distribution

  • 00889795140708 ()
P11-900-CASB

  • Device sterilization/disinfection container, reusable

APEX 3D S Total Ankle Replacement System - 00889795140685

Short Stem Tibia System, Tray 2
Paragon 28, Inc.
P11-900-0002
In Commercial Distribution

  • 00889795140685 ()
P11-900-0002

  • Device sterilization/disinfection container, reusable

APEX 3D S Total Ankle Replacement System - 00889795140661

Apex 3D-S TAR X-ray Templates Packet
Paragon 28, Inc.
P11-900-TEMP
In Commercial Distribution

  • 00889795140661 ()
P11-900-TEMP

  • Surgical implant template, reusable

APEX 3D S Total Ankle Replacement System - 00889795140647

Short Stem Tibia, Instrument, Drill Wrench
Paragon 28, Inc.
P11-854-WR01
In Commercial Distribution

  • 00889795140647 ()
P11-854-WR01

  • Surgical torque wrench, reusable

APEX 3D Total Ankle Replacement System - 00889795140630

Right Angle Drill - Hex Socket Driver
Paragon 28, Inc.
P11-854-RAD1-17
In Commercial Distribution

  • 00889795140630 ()
P11-854-RAD1-17

  • Surgical screwdriver, reusable

APEX 3D S Total Ankle Replacement System - 00889795140616

Short Stem Tibia, Instrument, Right Angle Drill
Paragon 28, Inc.
P11-854-RAD1
In Commercial Distribution

  • 00889795140616 ()
P11-854-RAD1

  • Fluted surgical drill bit, reusable
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