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

Clear

Asfora Anterior Cervical Plate System - M364111106FD2470 Catalog Number :

Device Description : 2 Level, 47mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 2 Level, 47mm 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 - M364111106FD2500 Catalog Number :

Device Description : 2 Level, 50mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 2 Level, 50mm 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 - M364111106FD2710 Catalog Number :

Device Description : Screw Extractor Sleeve

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : KWQ

Prescription Use : No

Device Count : 1

Asfora Anterior Cervical Plate System - M364111106FD2720 Catalog Number :

Device Description : Screw Extractor Driver

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : KWQ

Prescription Use : No

Device Count : 1

Asfora Anterior Cervical Plate System - M364111106FD2730 Catalog Number :

Device Description : Screw Extractor Wedge Lock

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : KWQ

Prescription Use : No

Device Count : 1

Asfora Anterior Cervical Plate System - M364111106FD280 Catalog Number :

Device Description : Screw Retention Driver

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : KWQ

Prescription Use : No

Device Count : 1

Asfora Anterior Cervical Plate System - M364111106FD290 Catalog Number :

Device Description : Variable Angle Drill Guide

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : KWQ

Prescription Use : No

Device Count : 1

Asfora Anterior Cervical Plate System - M364111106FD350 Catalog Number :

Device Description : Plate Bender

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : KWQ

Prescription Use : No

Device Count : 1

Asfora Anterior Cervical Plate System - M364111106FD3510 Catalog Number :

Device Description : 3 Level, 51mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 3 Level, 51mm 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 - M364111106FD3540 Catalog Number :

Device Description : 3 Level, 54mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 3 Level, 54mm 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

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