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) (1)

Premarket Exempt

No Yes

Clear

ATLANTIS ESSENTIALS™ Anterior Cervical Plate System - 20643169587353 Catalog Number :

Device Description : SCREW G73733042017 4.0X17 SLF-TAP 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 - 20643169587360 Catalog Number :

Device Description : SCREW G73733042018 4.0X18 SLF-TAP 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 - 20643169587377 Catalog Number :

Device Description : SCREW G73733042019 4.0X19 SLF-TAP 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 - 20643169587384 Catalog Number :

Device Description : SCREW G73733042020 4.0X20 SLF-TAP 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 - 20643169587438 Catalog Number :

Device Description : SCREW G73733042511 4.5X11 SLF-TAP 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 - 20643169587445 Catalog Number :

Device Description : SCREW G73733042513 4.5X13 SLF-TAP 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 - 20643169587452 Catalog Number :

Device Description : SCREW G73733042515 4.5X15 SLF-TAP 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 - 20643169587469 Catalog Number :

Device Description : SCREW G73733042517 4.5X17 SLF-TAP 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 - 20643169587865 Catalog Number :

Device Description : SCREW G73733032010 4.0X10 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 - 20643169587872 Catalog Number :

Device Description : SCREW G73733032011 4.0X11 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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