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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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Meridian - 10889981231422

Fixed Angle Screw, 5.5mm Dia. x 55mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-005555
In Commercial Distribution

  • 10889981231422 ()
RA1-005555

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981231415

Fixed Angle Screw, 5.5mm Dia. x 50mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-005550
In Commercial Distribution

  • 10889981231415 ()
RA1-005550

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981231408

Fixed Angle Screw, 5.5mm Dia. x 45mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-005545
In Commercial Distribution

  • 10889981231408 ()
RA1-005545

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981231392

Fixed Angle Screw, 5.5mm Dia. x 40mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-005540
In Commercial Distribution

  • 10889981231392 ()
RA1-005540

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981216504

No-Profile Lock Removal Tool
SEASPINE ORTHOPEDICS CORPORATION
RA2-005003
In Commercial Distribution

  • 10889981216504 ()
RA2-005003

  • Orthopaedic inorganic implant inserter/extractor, reusable

Meridian - 10889981216443

Inline Fixation Anchor Inserter
SEASPINE ORTHOPEDICS CORPORATION
RA2-003025
In Commercial Distribution

  • 10889981216443 ()
RA2-003025

  • Orthopaedic inorganic implant inserter/extractor, reusable

Meridian - 10889981216207

No-Profile Lock Inserter No Sleeve
SEASPINE ORTHOPEDICS CORPORATION
RA2-001015
In Commercial Distribution

  • 10889981216207 ()
RA2-001015

  • Orthopaedic inorganic implant inserter/extractor, reusable

Meridian - 10889981216191

Offset Interbody Inserter Tip 43mm x 30mm
SEASPINE ORTHOPEDICS CORPORATION
RA2-001014
In Commercial Distribution

  • 10889981216191 ()
RA2-001014

  • Orthopaedic inorganic implant inserter/extractor, reusable

Meridian - 10889981216184

Offset Interbody Inserter Tip 39mm x 30mm
SEASPINE ORTHOPEDICS CORPORATION
RA2-001013
In Commercial Distribution

  • 10889981216184 ()
RA2-001013

  • Orthopaedic inorganic implant inserter/extractor, reusable

Meridian - 10889981216177

Offset Interbody Inserter Tip 39mm x 27mm
SEASPINE ORTHOPEDICS CORPORATION
RA2-001012
In Commercial Distribution

  • 10889981216177 ()
RA2-001012

  • Orthopaedic inorganic implant inserter/extractor, reusable

Meridian - 10889981216160

Offset Interbody Inserter Tip 35mm x 27mm
SEASPINE ORTHOPEDICS CORPORATION
RA2-001011
In Commercial Distribution

  • 10889981216160 ()
RA2-001011

  • Orthopaedic inorganic implant inserter/extractor, reusable

Meridian - 10889981216153

Offset Interbody Inserter Tip 31mm x 24mm
SEASPINE ORTHOPEDICS CORPORATION
RA2-001010
In Commercial Distribution

  • 10889981216153 ()
RA2-001010

  • Orthopaedic inorganic implant inserter/extractor, reusable

Meridian - 10889981216139

Offset Interbody Inserter
SEASPINE ORTHOPEDICS CORPORATION
RA2-001007
In Commercial Distribution

  • 10889981216139 ()
RA2-001007

  • Orthopaedic inorganic implant inserter/extractor, reusable

Meridian - 10889981216108

Interbody Inserter
SEASPINE ORTHOPEDICS CORPORATION
RA2-001003
In Commercial Distribution

  • 10889981216108 ()
RA2-001003

  • Orthopaedic inorganic implant inserter/extractor, reusable

Meridian - 10889981216085

Guide Shaft
SEASPINE ORTHOPEDICS CORPORATION
RA2-001001
In Commercial Distribution

  • 10889981216085 ()
RA2-001001

  • Orthopaedic inorganic implant inserter/extractor, reusable

Meridian - 10889981214487

Fixed Angle Screw, 6.0mm Dia. x 35mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-006035
In Commercial Distribution

  • 10889981214487 ()
RA1-006035

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981214470

Fixed Angle Screw, 6.0mm Dia. x 30mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-006030
In Commercial Distribution

  • 10889981214470 ()
RA1-006030

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981214463

Fixed Angle Screw, 6.0mm Dia. x 25mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-006025
In Commercial Distribution

  • 10889981214463 ()
RA1-006025

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981214456

Fixed Angle Screw, 6.0mm Dia. x 20mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-006020
In Commercial Distribution

  • 10889981214456 ()
RA1-006020

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981214449

Fixed Angle Screw, 6.0mm Dia. x 15mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-006015
In Commercial Distribution

  • 10889981214449 ()
RA1-006015

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981214432

Fixed Angle Screw, 5.5mm Dia. x 35mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-005535
In Commercial Distribution

  • 10889981214432 ()
RA1-005535

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981214425

Fixed Angle Screw, 5.5mm Dia. x 30mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-005530
In Commercial Distribution

  • 10889981214425 ()
RA1-005530

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981214418

Fixed Angle Screw, 5.5mm Dia. x 25mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-005525
In Commercial Distribution

  • 10889981214418 ()
RA1-005525

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981214401

Fixed Angle Screw, 5.5mm Dia. x 20mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-005520
In Commercial Distribution

  • 10889981214401 ()
RA1-005520

  • Spinal bone screw, non-bioabsorbable

Meridian - 10889981214395

Fixed Angle Screw, 5.5mm Dia. x 15mm
SEASPINE ORTHOPEDICS CORPORATION
RA1-005515
In Commercial Distribution

  • 10889981214395 ()
RA1-005515

  • Spinal bone screw, non-bioabsorbable

Specials - 10889981211981

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

  • 10889981211981 ()
SR-0369

  • Orthopaedic inorganic implant inserter/extractor, reusable

Reef TH - 10889981207090

Inserter, 9w
SEASPINE ORTHOPEDICS CORPORATION
TH2-001009
In Commercial Distribution

  • 10889981207090 ()
TH2-001009

  • Orthopaedic inorganic implant inserter/extractor, reusable

Specials - 10889981192150

Regatta Angled Inserter, 40° x 0°
SEASPINE ORTHOPEDICS CORPORATION
SR-0396-02
In Commercial Distribution

  • 10889981192150 ()
SR-0396-02

  • Orthopaedic inorganic implant inserter/extractor, reusable

Specials - 10889981192143

Regatta Angled Inserter, 40° x 20°
SEASPINE ORTHOPEDICS CORPORATION
SR-0396-01
In Commercial Distribution

  • 10889981192143 ()
SR-0396-01

  • Orthopaedic inorganic implant inserter/extractor, reusable

Specials - 10889981189457

Hollywood Angled Inserter
SEASPINE ORTHOPEDICS CORPORATION
SR-0443
In Commercial Distribution

  • 10889981189457 ()
SR-0443

  • Orthopaedic inorganic implant inserter/extractor, reusable

Ventura NanoMetalene Sterile - 10889981170356

Ventura NanoMetalene Offset MIS Inserter
SEASPINE ORTHOPEDICS CORPORATION
93-3806
In Commercial Distribution

  • 10889981170356 ()
93-3806

  • Orthopaedic inorganic implant inserter/extractor, reusable

Ventura NanoMetalene Sterile - 10889981170349

Ventura NanoMetalene Straight Inserter
SEASPINE ORTHOPEDICS CORPORATION
93-3805
In Commercial Distribution

  • 10889981170349 ()
93-3805

  • Orthopaedic inorganic implant inserter/extractor, reusable

Regatta Lateral System - 10889981162313

Regatta Angled Inserter
SEASPINE ORTHOPEDICS CORPORATION
36-90-3001
In Commercial Distribution

  • 10889981162313 ()
36-90-3001

  • Orthopaedic inorganic implant inserter/extractor, reusable

Regatta Lateral System - 10889981162306

Regatta Lateral Inserter
SEASPINE ORTHOPEDICS CORPORATION
36-90-3000
In Commercial Distribution

  • 10889981162306 ()
36-90-3000

  • Orthopaedic inorganic implant inserter/extractor, reusable

Integra Expandable Interbody - 10889981049539

15mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
SEASPINE ORTHOPEDICS CORPORATION
98-2115
Not in Commercial Distribution

  • 10889981049539 ()

  • 15mm (22x10mm, 0°)
98-2115

  • Orthopaedic inorganic implant inserter/extractor, reusable

Integra Expandable Interbody - 10889981049522

14mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
SEASPINE ORTHOPEDICS CORPORATION
98-2114
Not in Commercial Distribution

  • 10889981049522 ()

  • 14mm (22x10mm, 0°)
98-2114

  • Orthopaedic inorganic implant inserter/extractor, reusable

Integra Expandable Interbody - 10889981049515

13mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
SEASPINE ORTHOPEDICS CORPORATION
98-2113
Not in Commercial Distribution

  • 10889981049515 ()

  • 13mm (22x10mm, 0°)
98-2113

  • Orthopaedic inorganic implant inserter/extractor, reusable

Integra Expandable Interbody - 10889981049508

12mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
SEASPINE ORTHOPEDICS CORPORATION
98-2112
Not in Commercial Distribution

  • 10889981049508 ()

  • 12mm (22x10mm, 0°)
98-2112

  • Orthopaedic inorganic implant inserter/extractor, reusable

Integra Expandable Interbody - 10889981049492

11mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
SEASPINE ORTHOPEDICS CORPORATION
98-2111
Not in Commercial Distribution

  • 10889981049492 ()

  • 11mm (22x10mm, 0°)
98-2111

  • Orthopaedic inorganic implant inserter/extractor, reusable

Integra Expandable Interbody - 10889981049485

10mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
SEASPINE ORTHOPEDICS CORPORATION
98-2110
In Commercial Distribution

  • 10889981049485 ()

  • 10mm (22x10mm, 0°)
98-2110

  • Orthopaedic inorganic implant inserter/extractor, reusable

Integra Expandable Interbody - 10889981049478

9mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
SEASPINE ORTHOPEDICS CORPORATION
98-2109
Not in Commercial Distribution

  • 10889981049478 ()

  • 9mm (22x10mm, 0°)
98-2109

  • Orthopaedic inorganic implant inserter/extractor, reusable

Integra Expandable Interbody - 10889981049461

8mm Trial (22x10mm, 0 deg). The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
SEASPINE ORTHOPEDICS CORPORATION
98-2108
Not in Commercial Distribution

  • 10889981049461 ()

  • 8mm (22x10mm, 0°)
98-2108

  • Orthopaedic inorganic implant inserter/extractor, reusable

Integra Expandable Interbody - 10889981049454

6mm Starter Trial. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
SEASPINE ORTHOPEDICS CORPORATION
98-2105
Not in Commercial Distribution

  • 10889981049454 ()

  • 6mm
98-2105

  • Orthopaedic inorganic implant inserter/extractor, reusable

Integra Expandable Interbody - 10889981049447

12mm Wide Removal Tool. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
SEASPINE ORTHOPEDICS CORPORATION
98-2012
Not in Commercial Distribution

  • 10889981049447 ()

  • 12mm
98-2012

  • Orthopaedic inorganic implant inserter/extractor, reusable

Integra Expandable Interbody - 10889981049430

Removal Tool. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
SEASPINE ORTHOPEDICS CORPORATION
98-2011
Not in Commercial Distribution

  • 10889981049430 ()
98-2011

  • Orthopaedic inorganic implant inserter/extractor, reusable

Integra Expandable Interbody - 10889981049423

Expansion Driver. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
SEASPINE ORTHOPEDICS CORPORATION
98-2010
Not in Commercial Distribution

  • 10889981049423 ()

  • 10mm
98-2010

  • Orthopaedic inorganic implant inserter/extractor, reusable

Integra Expandable Interbody - 10889981049409

Inserter. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
SEASPINE ORTHOPEDICS CORPORATION
98-2001
Not in Commercial Distribution

  • 10889981049409 ()
98-2001

  • Orthopaedic inorganic implant inserter/extractor, reusable

Integra Expandable Interbody - 10889981049393

Inserter. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
SEASPINE ORTHOPEDICS CORPORATION
98-2000
Not in Commercial Distribution

  • 10889981049393 ()
98-2000

  • Orthopaedic inorganic implant inserter/extractor, reusable

Vu aPod™ - L - 10889981048112

Straight Inserter
SEASPINE ORTHOPEDICS CORPORATION
31-40-0294
In Commercial Distribution

  • 10889981048112 ()
31-40-0294

  • Orthopaedic inorganic implant inserter/extractor, reusable

Vu aPod™ - L - 10889981048105

Straight Lateral Inserter Draw Rod, 8mm Lordotic
SEASPINE ORTHOPEDICS CORPORATION
31-40-0282
In Commercial Distribution

  • 10889981048105 ()
31-40-0282

  • Orthopaedic inorganic implant inserter/extractor, reusable
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