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) (5)

Premarket Exempt

No Yes

Clear

Asfora Bullet Cage System - M364119905FD630 Catalog Number :

Device Description : 14mm 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 - M364119905FD640 Catalog Number :

Device Description : Allen Wrench

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

Asfora Bullet Cage System - M364119905FD70 Catalog Number :

Device Description : 10mm Drill Bit

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

Asfora Bullet Cage System - M364119905FD80 Catalog Number :

Device Description : 12mm Drill Bit

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

Asfora Bullet Cage System - M364119905FD90 Catalog Number :

Device Description : 14mm Drill Bit

Device Class : 2

Duns Number: 003815548

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

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