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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No Description
7D Surgical ULC
11-0079
In Commercial Distribution

  • 00628341520690 ()


  • Surgical optical-tracking spatial marker connector
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 NERVE ROOT RETRACTOR, 14mm
Avalign Technologies, Inc.
00-5489-0914-99
In Commercial Distribution

  • 00190776149475 ()


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

  • 00190776149468 ()


  • Nerve/vessel retractor
BAYONET NERVE ROOT 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
SeaSpine Bi-Ostetic Cancellous Blocks is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. SeaSpine Bi-Ostetic Cancellous Blocks is safe and has excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. SeaSpine Bi-Ostetic Cancellous Blocks is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission. SeaSpine Bi-Ostetic Cancellous Blocks is an osteoconductive bone substitute shaped as blocks that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The blocks may be pressed into the void or into the surgical site by hand. The SeaSpine Bi-Ostetic Cancellous Blocks provide void filling material that acts as a temporary support medium. The blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. SeaSpine Bi-Ostetic Cancellous Blocks is biocompatible and resorbs in the body as bone ingrowth occurs.
BERKELEY ADVANCED BIOMATERIALS, LLC
SBiO-XYZ400606P
In Commercial Distribution

  • 00858418003966 ()
SBiO-XYZ400606P

  • Bone matrix implant, synthetic, non-antimicrobial
No Description
LUMITEX, INC.
007979
In Commercial Distribution

  • 00812432022891 ()
91-8412

  • Fibreoptic light cable
No Description
LUMITEX, INC.
007978
In Commercial Distribution

  • 00812432022884 ()
91-8411

  • Fibreoptic light cable
No Description
LUMITEX, INC.
007977
In Commercial Distribution

  • 00812432022877 ()
91-8410

  • Fibreoptic light cable
No Description
LUMITEX, INC.
007976
In Commercial Distribution

  • 00812432022860 ()
91-8409

  • Fibreoptic light cable
No Description
LUMITEX, INC.
009133
In Commercial Distribution

  • 00812432021412 ()
91-8480

  • Surgical instrument fibreoptic light
No Description
LUMITEX, INC.
012214
In Commercial Distribution

  • 00812432021399 ()
MR2-006010

  • Surgical instrument fibreoptic light
No Description
LUMITEX, INC.
008329
In Commercial Distribution

  • 00812432020675 ()
91-8408

  • Fibreoptic light cable
No Description
Provision
86-0712
In Commercial Distribution

  • B504OM8607120 ()


  • Drilling power tool attachment, basic
Interbody, 16x14x9mm, 10 Degree, Sterile
SEASPINE ORTHOPEDICS CORPORATION
85-1309-S
In Commercial Distribution

  • 00889981124734 ()

  • 16x14x9mm, 10 Degree
85-1309-S

  • Vertebral body prosthesis, non-sterile
Interbody, 16x14x8mm, 10 Degree, Sterile
SEASPINE ORTHOPEDICS CORPORATION
85-1308-S
In Commercial Distribution

  • 00889981124727 ()

  • 16x14x8mm, 10 Degree
85-1308-S

  • Vertebral body prosthesis, non-sterile
Interbody, 16x14x7mm, 10 Degree, Sterile
SEASPINE ORTHOPEDICS CORPORATION
85-1307-S
In Commercial Distribution

  • 00889981124710 ()

  • 16x14x7mm, 10 Degree
85-1307-S

  • Vertebral body prosthesis, non-sterile
Interbody, 20x15x12mm, 7 Degree, Sterile
SEASPINE ORTHOPEDICS CORPORATION
85-1112-S
In Commercial Distribution

  • 00889981124703 ()

  • 20x15x12mm, 7 Degree
85-1112-S

  • Vertebral body prosthesis, non-sterile
Interbody, 20x15x11mm, 7 Degree, Sterile
SEASPINE ORTHOPEDICS CORPORATION
85-1111-S
In Commercial Distribution

  • 00889981124697 ()

  • 20x15x11mm, 7 Degree
85-1111-S

  • Vertebral body prosthesis, non-sterile
Interbody, 20x15x10mm, 7 Degree, Sterile
SEASPINE ORTHOPEDICS CORPORATION
85-1110-S
In Commercial Distribution

  • 00889981124680 ()

  • 20x15x10mm, 7 Degree
85-1110-S

  • Vertebral body prosthesis, non-sterile
Interbody, 20x15x9mm, 7 Degree, Sterile
SEASPINE ORTHOPEDICS CORPORATION
85-1109-S
In Commercial Distribution

  • 00889981124673 ()

  • 20x15x9mm, 7 Degree
85-1109-S

  • Vertebral body prosthesis, non-sterile
Interbody, 20x15x8mm, 7 Degree, Sterile
SEASPINE ORTHOPEDICS CORPORATION
85-1108-S
In Commercial Distribution

  • 00889981124666 ()

  • 20x15x8mm, 7 Degree
85-1108-S

  • Vertebral body prosthesis, non-sterile
Interbody, 20x15x7mm, 7 Degree, Sterile
SEASPINE ORTHOPEDICS CORPORATION
85-1107-S
In Commercial Distribution

  • 00889981124659 ()

  • 20x15x7mm, 7 Degree
85-1107-S

  • Vertebral body prosthesis, non-sterile
Interbody, 20x15x6mm, 7 Degree, Sterile
SEASPINE ORTHOPEDICS CORPORATION
85-1106-S
In Commercial Distribution

  • 00889981124642 ()

  • 20x15x6mm, 7 Degree
85-1106-S

  • Vertebral body prosthesis, non-sterile
Interbody, 20x15x5mm, 7 Degree, Sterile
SEASPINE ORTHOPEDICS CORPORATION
85-1105-S
In Commercial Distribution

  • 00889981124635 ()

  • 20x15x5mm, 7 Degree
85-1105-S

  • Vertebral body prosthesis, non-sterile
Interbody, 18x15x12mm, 7 Degree, Sterile
SEASPINE ORTHOPEDICS CORPORATION
85-1012-S
In Commercial Distribution

  • 00889981124628 ()

  • 18x15x12mm, 7 Degree
85-1012-S

  • Vertebral body prosthesis, non-sterile
Interbody, 18x15x11mm, 7 Degree, Sterile
SEASPINE ORTHOPEDICS CORPORATION
85-1011-S
In Commercial Distribution

  • 00889981124611 ()

  • 18x15x11mm, 7 Degree
85-1011-S

  • Vertebral body prosthesis, non-sterile
Interbody, 18x15x10mm, 7 Degree, Sterile
SEASPINE ORTHOPEDICS CORPORATION
85-1010-S
In Commercial Distribution

  • 00889981124604 ()

  • 18x15x10mm, 7 Degree
85-1010-S

  • Vertebral body prosthesis, non-sterile
Interbody, 18x15x9mm, 7 Degree, Sterile
SEASPINE ORTHOPEDICS CORPORATION
85-1009-S
In Commercial Distribution

  • 00889981124598 ()

  • 18x15x9mm, 7 Degree
85-1009-S

  • Vertebral body prosthesis, non-sterile
Interbody, 18x15x8mm, 7 Degree, Sterile
SEASPINE ORTHOPEDICS CORPORATION
85-1008-S
In Commercial Distribution

  • 00889981124581 ()

  • 18x15x8mm, 7 Degree
85-1008-S

  • Vertebral body prosthesis, non-sterile
Interbody, 18x15x7mm, 7 Degree, Sterile
SEASPINE ORTHOPEDICS CORPORATION
85-1007-S
In Commercial Distribution

  • 00889981124574 ()

  • 18x15x7mm, 7 Degree
85-1007-S

  • Vertebral body prosthesis, non-sterile
Interbody, 18x15x6mm, 7 Degree, Sterile
SEASPINE ORTHOPEDICS CORPORATION
85-1006-S
In Commercial Distribution

  • 00889981124567 ()

  • 18x15x6mm, 7 Degree
85-1006-S

  • Vertebral body prosthesis, non-sterile
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