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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 Type Device Class Implantable

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Redondo-L™ - 10889981035044

Redondo-L 45mm x 18mm x 8mm, 8 Deg. Redondo-L is intended to promote spinal fusion by acting as a spacer and holding bone graft. The implants have teeth on the superior and inferior surfaces and a central canal for receiving bone graft. These devices are available in a variety of lengths, widths, and heights to accommodate variations in pathology and patient anatomy. All Redondo-L implants are manufactured from PEEK OPTIMA®(polyetheretherketone, ASTM F-2026) with tantalum (ASTM F-560) radiographic wires and/or beads.
SEASPINE ORTHOPEDICS CORPORATION
36-4516
Not in Commercial Distribution

  • 10889981035044 ()

  • 45mm x 18mm x 16mm, 8 degrees
36-4516

  • Vertebral body prosthesis, non-sterile

Redondo-L™ - 10889981035037

Redondo-L 45mm x 18mm x 8mm, 8 Deg.
SEASPINE ORTHOPEDICS CORPORATION
36-4514
In Commercial Distribution

  • 10889981035037 ()

  • 45mm x 18mm x 14mm, 8 degrees
36-4514

  • Vertebral body prosthesis, non-sterile

Redondo-L™ - 10889981035020

Redondo-L 45mm x 18mm x 8mm, 8 Deg.
SEASPINE ORTHOPEDICS CORPORATION
36-4512
In Commercial Distribution

  • 10889981035020 ()

  • 45mm x 18mm x 12mm, 8 degrees
36-4512

  • Vertebral body prosthesis, non-sterile

Redondo-L™ - 10889981035013

Redondo-L 45mm x 18mm x 8mm, 8 Deg.
SEASPINE ORTHOPEDICS CORPORATION
36-4510
In Commercial Distribution

  • 10889981035013 ()

  • 45mm x 18mm x 10mm, 8 degrees
36-4510

  • Vertebral body prosthesis, non-sterile

Redondo-L™ - 10889981035006

Redondo-L 45mm x 18mm x 8mm, 8 Deg.
SEASPINE ORTHOPEDICS CORPORATION
36-4508
In Commercial Distribution

  • 10889981035006 ()

  • 45mm x 18mm x 8mm, 8 degrees
36-4508

  • Vertebral body prosthesis, non-sterile

SeaSpine Spacer System - Hollywood™ NanoMetalene® - 10889981034719

Hollywood NM Implant, 11mm x 27mm x 14mm, Lordotic
SEASPINE ORTHOPEDICS CORPORATION
34-5114
In Commercial Distribution

  • 10889981034719 ()

  • 11mm x 27mm x 14mm
34-5114

  • Vertebral body prosthesis, non-sterile

SeaSpine Spacer System - Hollywood™ NanoMetalene® - 10889981034702

Hollywood NM Implant, 11mm x 27mm x 13mm, Lordotic
SEASPINE ORTHOPEDICS CORPORATION
34-5113
In Commercial Distribution

  • 10889981034702 ()

  • 11mm x 27mm x 13mm
34-5113

  • Vertebral body prosthesis, non-sterile

SeaSpine Spacer System - Hollywood™ NanoMetalene® - 10889981034696

Hollywood NM Implant, 11mm x 27mm x 12mm, Lordotic
SEASPINE ORTHOPEDICS CORPORATION
34-5112
In Commercial Distribution

  • 10889981034696 ()

  • 11mm x 27mm x 12mm
34-5112

  • Vertebral body prosthesis, non-sterile

SeaSpine Spacer System - Hollywood™ NanoMetalene® - 10889981034689

Hollywood NM Implant, 11mm x 27mm x 11mm, Lordotic
SEASPINE ORTHOPEDICS CORPORATION
34-5111
In Commercial Distribution

  • 10889981034689 ()

  • 11mm x 27mm x 11mm
34-5111

  • Vertebral body prosthesis, non-sterile

SeaSpine Spacer System - Hollywood™ NanoMetalene® - 10889981034672

Hollywood NM Implant, 11mm x 27mm x 10mm, Lordotic
SEASPINE ORTHOPEDICS CORPORATION
34-5110
In Commercial Distribution

  • 10889981034672 ()

  • 11mm x 27mm x 10mm
34-5110

  • Vertebral body prosthesis, non-sterile

SeaSpine Spacer System - Hollywood™ NanoMetalene® - 10889981034665

Hollywood NM Implant, 11mm x 27mm x 9mm, Lordotic
SEASPINE ORTHOPEDICS CORPORATION
34-5109
In Commercial Distribution

  • 10889981034665 ()

  • 11mm x 27mm x 9mm
34-5109

  • Vertebral body prosthesis, non-sterile

SeaSpine Spacer System - Hollywood™ NanoMetalene® - 10889981034658

Hollywood NM Implant, 11mm x 27mm x 8mm, Lordotic
SEASPINE ORTHOPEDICS CORPORATION
34-5108
In Commercial Distribution

  • 10889981034658 ()

  • 11mm x 27mm x 8mm
34-5108

  • Vertebral body prosthesis, non-sterile

SeaSpine Spacer System - Hollywood™ NanoMetalene® - 10889981034641

Hollywood NM Implant, 11mm x 27mm x 7mm, Lordotic
SEASPINE ORTHOPEDICS CORPORATION
34-5107
In Commercial Distribution

  • 10889981034641 ()

  • 11mm x 27mm x 7mm
34-5107

  • Vertebral body prosthesis, non-sterile

Pacifica™ - 10889981031619

Pacifica Implant 9mm x 24mm x 14mm
SEASPINE ORTHOPEDICS CORPORATION
33-2614
In Commercial Distribution

  • 10889981031619 ()
33-2614

  • Vertebral body prosthesis

Hollywood - 10889981031022

Hollywood Modular Trial, 11mm x 30mm x 14mm
SEASPINE ORTHOPEDICS CORPORATION
93-4214
In Commercial Distribution

  • 10889981031022 ()
93-4214

  • Spinal implant trial

Hollywood - 10889981031008

Hollywood Modular Trial, 11mm x 30mm x 12mm
SEASPINE ORTHOPEDICS CORPORATION
93-4212
In Commercial Distribution

  • 10889981031008 ()
93-4212

  • Spinal implant trial

Hollywood - 10889981030988

Hollywood Modular Trial, 11mm x 30mm x 10mm
SEASPINE ORTHOPEDICS CORPORATION
93-4210
In Commercial Distribution

  • 10889981030988 ()
93-4210

  • Spinal implant trial

Specials - 10889981326104

Angled Lateral Inserter, Modified Proximal Connection
SEASPINE ORTHOPEDICS CORPORATION
SR-1232
In Commercial Distribution

  • 10889981326104 ()
SR-1232

  • Orthopaedic inorganic implant inserter/extractor, reusable

Specials - 10889981326098

Lateral Inserter, Modified Proximal Connection
SEASPINE ORTHOPEDICS CORPORATION
SR-1229
In Commercial Distribution

  • 10889981326098 ()
SR-1229

  • Orthopaedic inorganic implant inserter/extractor, reusable

Specials - 10889981326050

Graft Loading Plunger
SEASPINE ORTHOPEDICS CORPORATION
SR-1125
In Commercial Distribution

  • 10889981326050 ()
SR-1125

  • Orthopaedic inorganic implant inserter/extractor, reusable

Specials - 10889981301095

Regatta Compound Angle Inserter, Caudal
SEASPINE ORTHOPEDICS CORPORATION
SR-0886
In Commercial Distribution

  • 10889981301095 ()
SR-0886

  • Orthopaedic inorganic implant inserter/extractor, reusable

Specials - 10889981301088

Regatta Compound Angle Inserter, Cranial
SEASPINE ORTHOPEDICS CORPORATION
SR-0885
In Commercial Distribution

  • 10889981301088 ()
SR-0885

  • Orthopaedic inorganic implant inserter/extractor, reusable

Meridian - 10889981285340

Fixed Angle Screw, 6.0mm Dia. x 30mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-406030
In Commercial Distribution

  • 10889981285340 ()
RA1-406030

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981285333

Fixed Angle Screw, 6.0mm Dia. x 25mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-406025
In Commercial Distribution

  • 10889981285333 ()
RA1-406025

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981285326

Fixed Angle Screw, 6.0mm Dia. x 20mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-406020
In Commercial Distribution

  • 10889981285326 ()
RA1-406020

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981285296

Fixed Angle Screw, 5.5mm Dia. x 30mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-405530
In Commercial Distribution

  • 10889981285296 ()
RA1-405530

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981285289

Fixed Angle Screw, 5.5mm Dia. x 25mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-405525
In Commercial Distribution

  • 10889981285289 ()
RA1-405525

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981285272

Fixed Angle Screw, 5.5mm Dia. x 20mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-405520
In Commercial Distribution

  • 10889981285272 ()
RA1405520

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981284497

Anterior Plate Inserter
SEASPINE ORTHOPEDICS CORPORATION
RA2-004006
In Commercial Distribution

  • 10889981284497 ()
RA2-004006

  • Orthopaedic inorganic implant inserter/extractor, reusable

Meridian - 10889981284428

Midline Inserter Modular Tip
SEASPINE ORTHOPEDICS CORPORATION
RA2-002003
In Commercial Distribution

  • 10889981284428 ()
RA2-002003

  • Orthopaedic inorganic implant inserter/extractor, reusable

Meridian - 10889981284404

Trial/Offset Interbody Inserter
SEASPINE ORTHOPEDICS CORPORATION
RA2-001022
In Commercial Distribution

  • 10889981284404 ()
RA2-001022

  • Orthopaedic inorganic implant inserter/extractor, reusable

Meridian - 10889981284398

Interbody Inserter
SEASPINE ORTHOPEDICS CORPORATION
RA2-001021
In Commercial Distribution

  • 10889981284398 ()
RA2-001021

  • Orthopaedic inorganic implant inserter/extractor, reusable

Meridian - 10889981284374

Offset Interbody Inserter Tip 43mm x 30mm
SEASPINE ORTHOPEDICS CORPORATION
RA2-001019
In Commercial Distribution

  • 10889981284374 ()
RA2-001019

  • Orthopaedic inorganic implant inserter/extractor, reusable

Meridian - 10889981284367

Offset Interbody Inserter Tip 39mm x 30mm
SEASPINE ORTHOPEDICS CORPORATION
RA2-001018
In Commercial Distribution

  • 10889981284367 ()
RA2-001018

  • Orthopaedic inorganic implant inserter/extractor, reusable

Meridian - 10889981284350

Offset Interbody Inserter Tip 35mm x 27mm
SEASPINE ORTHOPEDICS CORPORATION
RA2-001017
In Commercial Distribution

  • 10889981284350 ()
RA2-001017

  • Orthopaedic inorganic implant inserter/extractor, reusable

Meridian - 10889981284343

Offset Interbody Inserter Tip 31mm x 24mm
SEASPINE ORTHOPEDICS CORPORATION
RA2-001016
In Commercial Distribution

  • 10889981284343 ()
RA2-001016

  • Orthopaedic inorganic implant inserter/extractor, reusable

Specials - 10889981276027

Waveform TA Inserter
SEASPINE ORTHOPEDICS CORPORATION
SR-0677
In Commercial Distribution

  • 10889981276027 ()
SR-0677

  • Orthopaedic inorganic implant inserter/extractor, reusable

Explorer TO - 10889981275518

Inserter, Explorer TO
SEASPINE ORTHOPEDICS CORPORATION
ET2-101000
In Commercial Distribution

  • 10889981275518 ()
ET2-101000

  • Orthopaedic inorganic implant inserter/extractor, reusable

Specials - 10889981272661

Regatta 25° Medial/Lateral Angled Inserter
SEASPINE ORTHOPEDICS CORPORATION
SR-0608
In Commercial Distribution

  • 10889981272661 ()
SR-0608

  • Orthopaedic inorganic implant inserter/extractor, reusable

Specials - 10889981259259

Inserter 11w, Short
SEASPINE ORTHOPEDICS CORPORATION
SR-0595-11
In Commercial Distribution

  • 10889981259259 ()
SR-0595-11

  • Orthopaedic inorganic implant inserter/extractor, reusable

Specials - 10889981259242

Inserter 9w, Short
SEASPINE ORTHOPEDICS CORPORATION
SR-0595-09
In Commercial Distribution

  • 10889981259242 ()
SR-0595-09

  • Orthopaedic inorganic implant inserter/extractor, reusable

Specials - 10889981246167

Non-Impaction Inserter Knob
SEASPINE ORTHOPEDICS CORPORATION
SR-0369-07
In Commercial Distribution

  • 10889981246167 ()
SR-0369-07

  • Orthopaedic inorganic implant inserter/extractor, reusable

Meridian - 10889981231507

Fixed Angle Screw, 6.0mm Dia. x 65mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-006065
In Commercial Distribution

  • 10889981231507 ()
RA1-006065

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981231491

Fixed Angle Screw, 6.0mm Dia. x 60mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-006060
In Commercial Distribution

  • 10889981231491 ()
RA1-006060

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981231484

Fixed Angle Screw, 6.0mm Dia. x 55mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-006055
In Commercial Distribution

  • 10889981231484 ()
RA1-006055

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981231477

Fixed Angle Screw, 6.0mm Dia. x 50mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-006050
In Commercial Distribution

  • 10889981231477 ()
RA1-006050

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981231460

Fixed Angle Screw, 6.0mm Dia. x 45mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-006045
In Commercial Distribution

  • 10889981231460 ()
RA1-006045

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981231453

Fixed Angle Screw, 6.0mm Dia. x 40mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-006040
In Commercial Distribution

  • 10889981231453 ()
RA1-006040

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981231446

Fixed Angle Screw, 5.5mm Dia. x 65mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-005565
In Commercial Distribution

  • 10889981231446 ()
RA1-005565

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981231439

Fixed Angle Screw, 5.5mm Dia. x 60mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-005560
In Commercial Distribution

  • 10889981231439 ()
RA1-005560

  • Spinal bone screw, non-bioabsorbable
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