Address:6709 S. MINNESOTA AVE,SIOUX FALLS,SD,57108,US
Device Description : 3 Level, 57mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 3 Level, 57mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporarystabilization to the anterior spine during the development of cervical spinefusions (C2-T1) for the following indications: degenerative disc disease (DDD)(defined as neck pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies), spondylolisthesis, trauma (i.e.,fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis,kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Device Class : 2
Duns Number: 003815548
Premarket Exempt : No
Prescription Use : Yes
Device Description : Caliper
Device Class : 2
Duns Number: 003815548
Premarket Exempt : No
Prescription Use : No
Device Description : 3 Level, 60mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 3 Level, 60mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporarystabilization to the anterior spine during the development of cervical spinefusions (C2-T1) for the following indications: degenerative disc disease (DDD)(defined as neck pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies), spondylolisthesis, trauma (i.e.,fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis,kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Device Class : 2
Duns Number: 003815548
Premarket Exempt : No
Prescription Use : Yes
Device Description : 3 Level, 63mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 3 Level, 63mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporarystabilization to the anterior spine during the development of cervical spinefusions (C2-T1) for the following indications: degenerative disc disease (DDD)(defined as neck pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies), spondylolisthesis, trauma (i.e.,fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis,kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Device Class : 2
Duns Number: 003815548
Premarket Exempt : No
Prescription Use : Yes
Device Description : 3 Level, 66mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 3 Level, 66mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporarystabilization to the anterior spine during the development of cervical spinefusions (C2-T1) for the following indications: degenerative disc disease (DDD)(defined as neck pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies), spondylolisthesis, trauma (i.e.,fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis,kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Device Class : 2
Duns Number: 003815548
Premarket Exempt : No
Prescription Use : Yes
Device Description : 3 Level, 69mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 3 Level, 69mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporarystabilization to the anterior spine during the development of cervical spinefusions (C2-T1) for the following indications: degenerative disc disease (DDD)(defined as neck pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies), spondylolisthesis, trauma (i.e.,fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis,kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Device Class : 2
Duns Number: 003815548
Premarket Exempt : No
Prescription Use : Yes
Device Description : Sterilization Case
Device Class : 2
Duns Number: 003815548
Premarket Exempt : No
Prescription Use : No
Device Description : 3 Level, 72mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 3 Level, 72mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporarystabilization to the anterior spine during the development of cervical spinefusions (C2-T1) for the following indications: degenerative disc disease (DDD)(defined as neck pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies), spondylolisthesis, trauma (i.e.,fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis,kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Device Class : 2
Duns Number: 003815548
Premarket Exempt : No
Prescription Use : Yes
Device Description : 3 Level, 75mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 3 Level, 75mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporarystabilization to the anterior spine during the development of cervical spinefusions (C2-T1) for the following indications: degenerative disc disease (DDD)(defined as neck pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies), spondylolisthesis, trauma (i.e.,fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis,kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Device Class : 2
Duns Number: 003815548
Premarket Exempt : No
Prescription Use : Yes
Device Description : Fixed Angle Drill Guide
Device Class : 2
Duns Number: 003815548
Premarket Exempt : No
Prescription Use : No