MEDICAL DESIGNS LLC

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

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Appliance, Fixation, Spinal Intervertebral Body (KWQ) (10)

Premarket Exempt

No Yes

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Asfora Anterior Cervical Plate System - M364111106FD420 Catalog Number :

Device Description : Axial Drill Bit Handle

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : KWQ

Prescription Use : No

Device Count : 1

Asfora Anterior Cervical Plate System - M364111106FD430 Catalog Number :

Device Description : Axial Driver Handle

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : KWQ

Prescription Use : No

Device Count : 1

Asfora Anterior Cervical Plate System - M364111106FD4740 Catalog Number :

Device Description : 4 Level, 74mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 4 Level, 74mm 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

Asfora Anterior Cervical Plate System - M364111106FD4780 Catalog Number :

Device Description : 4 Level, 78mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 4 Level, 78mm 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

Asfora Anterior Cervical Plate System - M364111106FD4820 Catalog Number :

Device Description : 4 Level, 82mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 4 Level, 82mm 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

Asfora Anterior Cervical Plate System - M364111106FD4860 Catalog Number :

Device Description : 4 Level, 86mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 4 Level, 86mm 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

Asfora Anterior Cervical Plate System - M364111106FD4900 Catalog Number :

Device Description : 4 Level, 90mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 4 Level, 90mm 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

Asfora Anterior Cervical Plate System - M364111106FD4940 Catalog Number :

Device Description : 4 Level, 94mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 4 Level, 94mm 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

Asfora Anterior Cervical Plate System - M364111106FD7120 Catalog Number :

Device Description : 12mm Variable Angle Locking Screw

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Asfora Anterior Cervical Plate System - M364111106FD7140 Catalog Number :

Device Description : 14mm Variable Angle Locking Screw

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

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