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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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Sierra™ - 10889981042318

Closed Lateral Connector, 3.5 Rod. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-0035
In Commercial Distribution

  • 10889981042318 ()

  • 3.5
50-0035

  • Cannulated surgical drill bit, single-use

Vu a-POD™ - 10889981042301

45 Degree Offset Inserter
SEASPINE ORTHOPEDICS CORPORATION
33-40-0245
In Commercial Distribution

  • 10889981042301 ()

  • 45 Degree
33-40-0245

  • Orthopaedic implant inserter/extractor, reusable

Vu a-POD™ - 10889981042295

Starter Trial
SEASPINE ORTHOPEDICS CORPORATION
21-40-0110
In Commercial Distribution

  • 10889981042295 ()
21-40-0110

  • Orthopaedic implant inserter/extractor, reusable

Vu a-POD™ - 10889981042288

90 Degree Lateral Inserter
SEASPINE ORTHOPEDICS CORPORATION
21-40-0290
In Commercial Distribution

  • 10889981042288 ()

  • 90 Degree
21-40-0290

  • Orthopaedic implant inserter/extractor, reusable

Vu a-POD™ - 10889981042271

45 Degree Offset Inserter
SEASPINE ORTHOPEDICS CORPORATION
21-40-0245
In Commercial Distribution

  • 10889981042271 ()

  • 45 Degree
21-40-0245

  • Orthopaedic implant inserter/extractor, reusable

Vu a-POD™ - 10889981042264

15 Degree Offset Inserter
SEASPINE ORTHOPEDICS CORPORATION
21-40-0215
In Commercial Distribution

  • 10889981042264 ()

  • 15 Degree
21-40-0215

  • Orthopaedic implant inserter/extractor, reusable

Vu a-POD™ - 10889981042257

Anterior Inserter
SEASPINE ORTHOPEDICS CORPORATION
21-40-0200
In Commercial Distribution

  • 10889981042257 ()
21-40-0200

  • Orthopaedic implant inserter/extractor, reusable

Paramount IBF - 10889981041755

Intervertebral Body Fusion Implant, 32mm x 14mm x 6 (05-0364-01)
SEASPINE ORTHOPEDICS CORPORATION
29-TA-3214
In Commercial Distribution

  • 10889981041755 ()

  • 32mm x 14mm x 6
29-TA-3214

  • Vertebral body prosthesis, non-sterile

Paramount IBF - 10889981041748

Intervertebral Body Fusion Implant, 32mm x 13mm x 6 (05-0363-01)
SEASPINE ORTHOPEDICS CORPORATION
29-TA-3213
In Commercial Distribution

  • 10889981041748 ()

  • 32mm x 13mm x 6
29-TA-3213

  • Vertebral body prosthesis, non-sterile

Paramount IBF - 10889981041731

Intervertebral Body Fusion Implant, 32mm x 12mm x 6 (05-0362-01)
SEASPINE ORTHOPEDICS CORPORATION
29-TA-3212
In Commercial Distribution

  • 10889981041731 ()

  • 32mm x 12mm x 6
29-TA-3212

  • Vertebral body prosthesis, non-sterile
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