MEDTRONIC SOFAMOR DANEK, INC.

Address:4340 Swinnea Road,Memphis,TN,38118,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

APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY (KWQ) (10) APPLIANCE, FIXATION, SPINAL INTERLAMINAL (KWP) (6)

Premarket Exempt

No Yes

Clear

ATLANTIS ESSENTIALS™ Anterior Cervical Plate System - 20643169587889 Catalog Number :

Device Description : SCREW G73733032012 4.0X12 SLF-DRL FIX 2P

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : KWQ, KWP

Prescription Use : Yes

Device Count : 2

ATLANTIS ESSENTIALS™ Anterior Cervical Plate System - 20643169587896 Catalog Number :

Device Description : SCREW G73733032013 4.0X13 SLF-DRL FIX 2P

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 2

ATLANTIS ESSENTIALS™ Anterior Cervical Plate System - 20643169587902 Catalog Number :

Device Description : SCREW G73733032014 4.0X14 SLF-DRL FIX 2P

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : KWQ, KWP

Prescription Use : Yes

Device Count : 2

ATLANTIS ESSENTIALS™ Anterior Cervical Plate System - 20643169587919 Catalog Number :

Device Description : SCREW G73733032015 4.0X15 SLF-DRL FIX 2P

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 2

ATLANTIS ESSENTIALS™ Anterior Cervical Plate System - 20643169587926 Catalog Number :

Device Description : SCREW G73733032016 4.0X16 SLF-DRL FIX 2P

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : KWQ, KWP

Prescription Use : Yes

Device Count : 2

ATLANTIS ESSENTIALS™ Anterior Cervical Plate System - 20643169587933 Catalog Number :

Device Description : SCREW G73733032017 4.0X17 SLF-DRL FIX 2P

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : KWQ, KWP

Prescription Use : Yes

Device Count : 2

ATLANTIS ESSENTIALS™ Anterior Cervical Plate System - 20643169587940 Catalog Number :

Device Description : SCREW G73733032018 4.0X18 SLF-DRL FIX 2P

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : KWQ, KWP

Prescription Use : Yes

Device Count : 2

ATLANTIS ESSENTIALS™ Anterior Cervical Plate System - 20643169587957 Catalog Number :

Device Description : SCREW G73733032019 4.0X19 SLF-DRL FIX 2P

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : KWQ, KWP

Prescription Use : Yes

Device Count : 2

ATLANTIS ESSENTIALS™ Anterior Cervical Plate System - 20643169587964 Catalog Number :

Device Description : SCREW G73733032020 4.0X20 SLF-DRL FIX 2P

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 2

ATLANTIS ESSENTIALS™ Anterior Cervical Plate System - 20643169588015 Catalog Number :

Device Description : SCREW G73733032511 4.5X11 SLF-DRL FIX 2P

Device Class :

Duns Number: 830350380

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 2

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