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) (6) Bit, Drill (HTW) (1) Guide, Surgical, Instrument (FZX) (1) Handle, Scalpel (GDZ) (1) Sacroiliac Joint Fixation (OUR) (1) Screw, Fixation, Bone (HWC) (1)

Premarket Exempt

No Yes

Clear

SAMBA SCREW SYSTEM - M111109FD120 Catalog Number :

Device Description : Drill Gauge

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : HWC, OUR

Prescription Use : No

Device Count : 1

BULLET Tapered Intervertebral Distractors and Drills - M361111814FD20610 Catalog Number : 11-1814-FD2-06

Device Description : BULLET™ Tapered Intervertebral Drill, 6-3mm

Device Class : 1

Duns Number: 003815548

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Dakota Knife Handle - M364110204FD10 Catalog Number : 11-0204-FD1

Device Description : The Dakota Knife® Handle used in conjunction with the Dakota Knife® Blade is des The Dakota Knife® Handle used in conjunction with the Dakota Knife® Blade is designed for use in open, limited open, and minimally invasive carpal tunnel release surgery. The Dakota Knife® Blade is a single-use, disposable cutting instrument for transecting the transverse carpal ligament.

Device Class :

Duns Number: 003815548

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : Yes

Device Count : 1

Dakota Knife Blade® - M364110204FD20 Catalog Number : 11-0204-FD2

Device Description : The Dakota Knife® Blade is a stainless steel surgical instrument designed for us The Dakota Knife® Blade is a stainless steel surgical instrument designed for use in open, limited open, and minimally invasive carpal tunnel release surgery. The Dakota Knife® Blade is a single-use, disposable cutting instrument for transecting the transverse carpal ligament

Device Class :

Duns Number: 003815548

Premarket Exempt : Yes

Product Code : GDZ

Prescription Use : No

Device Count : 1

Asfora Anterior Cervical Plate System - M364111106FD120 Catalog Number :

Device Description : 12mm Drill Bit

Device Class :

Duns Number: 003815548

Premarket Exempt : No

Product Code : KWQ

Prescription Use : No

Device Count : 1

Asfora Anterior Cervical Plate System - M364111106FD1200 Catalog Number :

Device Description : 1 Level, 20mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 1 Level, 20mm 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 :

Duns Number: 003815548

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Asfora Anterior Cervical Plate System - M364111106FD1220 Catalog Number :

Device Description : 1 Level, 22mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 1 Level, 22mm 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 - M364111106FD1240 Catalog Number :

Device Description : 1 Level, 24mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 1 Level, 24mm 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 - M364111106FD1260 Catalog Number :

Device Description : 1 Level, 26mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 1 Level, 26mm 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 - M364111106FD1280 Catalog Number :

Device Description : 1 Level, 28mm Cervical Plate; The Asfora Anterior Cervical Plate System is inten 1 Level, 28mm 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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