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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Unlocking Assembly, A-O Male Seaspine
TECOMET INC.
UT101001
In Commercial Distribution

  • 00818069014520 ()


  • Surgical screwdriver, reusable
Unlocking Assembly, A-O Male Seaspine
TECOMET INC.
UT101001
In Commercial Distribution

  • 00818069014155 ()


  • Surgical screwdriver, reusable
4-Sided Cylindrical Handle, Fixed, SeaSpine Logo
Seaspine Orthopedics Corporation
SH2-100001
In Commercial Distribution

  • 10889981246174 ()
SH2-100001

  • Surgical instrument handle, non-torque-limiting
Driver Assy, Unlock Tool for Seaspine
Shukla Medical
MMI1223
In Commercial Distribution

  • B756MMI12230 ()


  • Surgical screwdriver, reusable
PEDICLE SUBTRACTION OSTEOTOMY SET
Avalign Technologies, Inc.
00-5489-0000-00
In Commercial Distribution

  • 00190776149628 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
POSTERIOR WALL REMOVAL KERRISON, 20mm
Avalign Technologies, Inc.
00-5489-1520-99
In Commercial Distribution

  • 00190776149611 ()


  • Orthopaedic joint/limb rongeur
STRAIGHT OSTEOTOME, 25mm
Avalign Technologies, Inc.
00-5489-1225-99
In Commercial Distribution

  • 00190776149604 ()


  • Orthopaedic osteotome
STRAIGHT OSTEOTOME, 13mm
Avalign Technologies, Inc.
00-5489-1213-99
In Commercial Distribution

  • 00190776149598 ()


  • Orthopaedic osteotome
STRAIGHT OSTEOTOME, 10mm
Avalign Technologies, Inc.
00-5489-1210-99
In Commercial Distribution

  • 00190776149581 ()


  • Orthopaedic osteotome
STRAIGHT OSTEOTOME, 6mm
Avalign Technologies, Inc.
00-5489-1206-99
In Commercial Distribution

  • 00190776149574 ()


  • Orthopaedic osteotome
8mm x 6mm VERTEBRAL BODY OSTEOTOME
Avalign Technologies, Inc.
00-5489-1186-99
In Commercial Distribution

  • 00190776149567 ()


  • Orthopaedic osteotome
6mm x 8mm VERTEBRAL BODY OSTEOTOME
Avalign Technologies, Inc.
00-5489-1168-99
In Commercial Distribution

  • 00190776149550 ()


  • Orthopaedic osteotome
POSTERIOR VERTEBRAL BODY PUNCH, 25mm WIDE
Avalign Technologies, Inc.
00-5489-0426-99
In Commercial Distribution

  • 00190776149543 ()


  • Orthopaedic osteotome
POSTERIOR VERTEBRAL BODY PUNCH, 25mm
Avalign Technologies, Inc.
00-5489-0425-99
In Commercial Distribution

  • 00190776149536 ()


  • Orthopaedic osteotome
POSTERIOR VERTEBRAL BODY PUNCH, 20mm WIDE
Avalign Technologies, Inc.
00-5489-0421-99
In Commercial Distribution

  • 00190776149529 ()


  • Orthopaedic osteotome
POSTERIOR VERTEBRAL BODY PUNCH, 20mm
Avalign Technologies, Inc.
00-5489-0420-99
In Commercial Distribution

  • 00190776149512 ()


  • Orthopaedic osteotome
ANGULAR TEMPLATE, 35degrees
Avalign Technologies, Inc.
00-5489-0335-99
In Commercial Distribution

  • 00190776149505 ()


  • Surgical implant template, reusable
ANGULAR TEMPLATE, 30degrees
Avalign Technologies, Inc.
00-5489-0330-99
In Commercial Distribution

  • 00190776149499 ()


  • Surgical implant template, reusable
ANGULAR TEMPLATE, 25degrees
Avalign Technologies, Inc.
00-5489-0325-99
In Commercial Distribution

  • 00190776149482 ()


  • Surgical implant template, reusable
BAYONET RETRACTOR, 14mm
Avalign Technologies, Inc.
00-5489-0914-99
In Commercial Distribution

  • 00190776149475 ()


  • Nerve/vessel retractor
BAYONET RETRACTOR, 12mm
Avalign Technologies, Inc.
00-5489-0912-99
In Commercial Distribution

  • 00190776149468 ()


  • Nerve/vessel retractor
BAYONET RETRACTOR, 10mm
Avalign Technologies, Inc.
00-5489-0910-99
In Commercial Distribution

  • 00190776149451 ()


  • Nerve/vessel retractor
ADJUSTABLE VERTEBRAL BODY RETRACTOR, 30mm
Avalign Technologies, Inc.
00-5489-0830-99
In Commercial Distribution

  • 00190776149444 ()


  • Self-retaining surgical retractor, reusable
ADJUSTABLE VERTEBRAL BODY RETRACTOR, 20mm
Avalign Technologies, Inc.
00-5489-0820-99
In Commercial Distribution

  • 00190776149437 ()


  • Self-retaining surgical retractor, reusable
ADJUSTABLE VERTEBRAL BODY RETRACTOR, 15mm
Avalign Technologies, Inc.
00-5489-0815-99
In Commercial Distribution

  • 00190776149420 ()


  • Self-retaining surgical retractor, reusable
PEDICLE SUBTRACTION OSTEOTOMY SET CASE
Avalign Technologies, Inc.
5287-100-001
In Commercial Distribution

  • 00190776149413 ()


  • Instrument tray, reusable
26mm Implant Caddy
Seaspine Orthopedics Corporation
98-2922
In Commercial Distribution

  • 10889981123857 ()

  • 26mm
98-2922

  • Instrument tray, reusable
22mm Implant Caddy
Seaspine Orthopedics Corporation
98-2921
In Commercial Distribution

  • 10889981123840 ()

  • 22mm
98-2921

  • Instrument tray, reusable
Guide Hex Rod
Seaspine Orthopedics Corporation
98-2205
In Commercial Distribution

  • 10889981123819 ()
98-2205

  • Surgical implant/trial-implant/sizer holder, reusable
Bone Funnel
Seaspine Orthopedics Corporation
98-2202
In Commercial Distribution

  • 10889981123802 ()
98-2202

  • Bone graft funnel
18mm Trial (22x10mm, 0 deg)
Seaspine Orthopedics Corporation
98-2118
In Commercial Distribution

  • 10889981123789 ()

  • 18mm (22x10mm, 0 Deg)
98-2118

  • Orthopaedic inorganic implant inserter/extractor, reusable
14mm Trial (22x10mm, 0 deg)
Seaspine Orthopedics Corporation
98-2114
In Commercial Distribution

  • 10889981123741 ()

  • 14mm (22x10mm, 0 Deg)
98-2114

  • Orthopaedic inorganic implant inserter/extractor, reusable
12mm Trial (22x10mm, 0 deg)
Seaspine Orthopedics Corporation
98-2112
In Commercial Distribution

  • 10889981123727 ()

  • 12mm (22x10mm, 0 Deg)
98-2112

  • Orthopaedic inorganic implant inserter/extractor, reusable
11mm Trial (22x10mm, 0 deg)
Seaspine Orthopedics Corporation
98-2111
In Commercial Distribution

  • 10889981123710 ()

  • 11mm (22x10mm, 0 Deg)
98-2111

  • Orthopaedic inorganic implant inserter/extractor, reusable
10mm Trial (22x10mm, 0 deg)
Seaspine Orthopedics Corporation
98-2110
In Commercial Distribution

  • 10889981123703 ()

  • 10mm (22x10mm, 0 Deg)
98-2110

  • Orthopaedic inorganic implant inserter/extractor, reusable
8mm Trial (22x10mm, 0 deg)
Seaspine Orthopedics Corporation
98-2108
In Commercial Distribution

  • 10889981123680 ()

  • 8mm (22x10mm, 0 Deg)
98-2108

  • Orthopaedic inorganic implant inserter/extractor, reusable
Removal Tool
Seaspine Orthopedics Corporation
98-2011
In Commercial Distribution

  • 10889981123659 ()
98-2011

  • Orthopaedic inorganic implant inserter/extractor, reusable
Inserter
Seaspine Orthopedics Corporation
98-2000
In Commercial Distribution

  • 10889981123611 ()
98-2000

  • Orthopaedic inorganic implant inserter/extractor, reusable
IMPLANT, 30mm LG, 10-15mm HT, 12mm WD, 0 DEG
Seaspine Orthopedics Corporation
82-3110
In Commercial Distribution

  • 10889981123598 ()

  • 30mm LG, 10-15mm HT, 12mm WD, 0 Deg
82-3110

  • Vertebral body prosthesis, non-sterile
IMPLANT, 30mm LG, 8-12mm HT, 12mm WD, 0 DEG
Seaspine Orthopedics Corporation
82-3108
In Commercial Distribution

  • 10889981123581 ()

  • 30mm LG, 8-12mm HT, 12mm WD, 0 Deg
82-3108

  • Vertebral body prosthesis, non-sterile
IMPLANT, 30mm LG, 10-15mm HT, 10mm WD, 0 DEG
Seaspine Orthopedics Corporation
82-3010
In Commercial Distribution

  • 10889981123567 ()

  • 30mm LG, 10-15mm HT, 10mm WD, 0 Deg
82-3010

  • Vertebral body prosthesis, non-sterile
IMPLANT, 26mm LG, 10-15mm HT, 12mm WD, 0 DEG
Seaspine Orthopedics Corporation
82-2710
In Commercial Distribution

  • 10889981123536 ()

  • 26mm LG, 10-15mm HT, 12mm WD, 0 Deg
82-2710

  • Vertebral body prosthesis, non-sterile
IMPLANT, 26mm LG, 12-18mm HT, 10mm WD, 0 DEG
Seaspine Orthopedics Corporation
82-2612
In Commercial Distribution

  • 10889981123512 ()

  • 26mm LG, 12-18mm HT, 10mm WD, 0 Deg
82-2612

  • Vertebral body prosthesis, non-sterile
IMPLANT, 26mm LG, 10-15mm HT, 10mm WD, 0 DEG
Seaspine Orthopedics Corporation
82-2610
In Commercial Distribution

  • 10889981123505 ()

  • 26mm LG, 10-15mm HT, 10mm WD, 0 Deg
82-2610

  • Vertebral body prosthesis, non-sterile
IMPLANT, 26mm LG, 8-12mm HT, 10mm WD, 0 DEG
Seaspine Orthopedics Corporation
82-2608
In Commercial Distribution

  • 10889981123499 ()

  • 26mm LG, 8-12mm HT, 10mm WD, 0 Deg
82-2608

  • Vertebral body prosthesis, non-sterile
IMPLANT, 22mm LG, 10-15mm HT, 12mm WD, 0 DEG
Seaspine Orthopedics Corporation
82-2310
In Commercial Distribution

  • 10889981123475 ()

  • 22mm LG, 10-15mm HT, 12mm WD, 0 Deg
82-2310

  • Vertebral body prosthesis, non-sterile
IMPLANT, 22mm LG, 8-12mm HT, 12mm WD, 0 DEG
Seaspine Orthopedics Corporation
82-2308
In Commercial Distribution

  • 10889981123468 ()

  • 22mm LG, 8-12mm HT, 12mm WD, 0 Deg
82-2308

  • Vertebral body prosthesis, non-sterile
IMPLANT, 22mm LG, 12-18mm HT, 10mm WD, 0 DEG
Seaspine Orthopedics Corporation
82-2212
In Commercial Distribution

  • 10889981123451 ()

  • 22mm LG, 12-18mm HT, 10mm WD, 0 Deg
82-2212

  • Vertebral body prosthesis, non-sterile
IMPLANT, 22mm LG, 10-15mm HT, 10mm WD, 0 DEG
Seaspine Orthopedics Corporation
82-2210
In Commercial Distribution

  • 10889981123444 ()

  • 22mm LG, 10-15mm HT, 10mm WD, 0 Deg
82-2210

  • Vertebral body prosthesis, non-sterile
Expandable IBD Implants
Seaspine Orthopedics Corporation
EXPIMP
In Commercial Distribution

  • 10889981123420 ()
EXPIMP

  • Instrument tray, reusable
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