MEDICAL DESIGNS LLC

Address:6709 S. MINNESOTA AVE,SIOUX FALLS,SD,57108,US

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Device Description : 1 Level, 30mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 1 Level, 30mm 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

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Device Description : 1 Level, 32mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 1 Level, 32mm 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

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Device Description : 1 Level, 34mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 1 Level, 34mm 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

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Device Description : 14mm Drill Bit

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : KWQ

Prescription Use : No

Device Count : 1

Device Description : 16mm Drill Bit

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : KWQ

Prescription Use : No

Device Count : 1

Device Description : 2 Level, 32mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 2 Level, 32mm 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

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Device Description : 2 Level, 35mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 2 Level, 35mm 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

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Device Description : 2 Level, 38mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 2 Level, 38mm 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

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Device Description : 2 Level, 41mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 2 Level, 41mm 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

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Device Description : 2 Level, 44mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 2 Level, 44mm 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

Product Code : KWQ

Prescription Use : Yes

Device Count : 1