MEDICAL DESIGNS LLC

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

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Filters

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

Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (10)

Premarket Exempt

Yes No

Clear

Asfora Bullet Cage System - M364119905FD480 Catalog Number :

Device Description : 14mm Long Modified Drill Guide

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

Asfora Bullet Cage System - M364119905FD490 Catalog Number :

Device Description : 16mm Long Modified Drill Guide

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

Asfora Bullet Cage System - M364119905FD50 Catalog Number :

Device Description : 6mm Drill Bit

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

Asfora Bullet Cage System - M364119905FD570 Catalog Number :

Device Description : Hudson Palm Handle

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

Asfora Bullet Cage System - M364119905FD580 Catalog Number :

Device Description : Hudson Axial Extreme Handle

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

Asfora Bullet Cage System - M364119905FD590 Catalog Number :

Device Description : 6mm Extended Disc Space Distractor

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

Asfora Bullet Cage System - M364119905FD60 Catalog Number :

Device Description : 8mm Drill Bit

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

Asfora Bullet Cage System - M364119905FD600 Catalog Number :

Device Description : 8mm Extended Disc Space Distractor

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

Asfora Bullet Cage System - M364119905FD610 Catalog Number :

Device Description : 10mm Extended Disc Space Distractor

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

Asfora Bullet Cage System - M364119905FD620 Catalog Number :

Device Description : 12mm Extended Disc Space Distractor

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

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