ATLANTIS ESSENTIALS™ Anterior Cervical Plate Syste

GUDID 20643169587902

SCREW G73733032014 4.0X14 SLF-DRL FIX 2P

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 20643169587902
• NIH Device Record Key: 8531b3a6-59f2-4b03-9bca-4455b4abbea8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATLANTIS ESSENTIALS™ Anterior Cervical Plate Syste
• Version Model Number: G73733032014
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 14 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169587908 [Unit of Use]
GS1	20643169587902 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152623

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-01-14

On-Brand Devices [ATLANTIS ESSENTIALS™ Anterior Cervical Plate Syste]

• 20643169587919: SCREW G73733032015 4.0X15 SLF-DRL FIX 2P
• 20643169587902: SCREW G73733032014 4.0X14 SLF-DRL FIX 2P
• 20643169587896: SCREW G73733032013 4.0X13 SLF-DRL FIX 2P
• 20643169587872: SCREW G73733032011 4.0X11 SLF-DRL FIX 2P
• 20643169587339: SCREW G73733042015 4.0X15 SLF-TAP FIX 2P
• 20643169587315: SCREW G73733042013 4.0X13 SLF-TAP FIX 2P
• 20643169587292: SCREW G73733042011 4.0X11 SLF-TAP FIX 2P
• 20643169575961: SCREW G73733132019 4.0X19 SLF-DRL VAR 2P
• 20643169575923: SCREW PK2 G73733132015 4.0X15 SLF-DR VAR
• 20643169575909: SCREW PK2 G73733132013 4.0X13 SLF-DR VAR
• 20643169575886: SCREW PK2 G73733132011 4.0X11 SLF-DR VAR
• 20643169575343: SCREW PK2 G73733142015 4.0X15 SLF-TP VAR
• 20643169575329: SCREW PK2 G73733142013 4.0X13 SLF-TP VAR
• 20643169575305: SCREW PK2 G73733142011 4.0X11 SLF-TP VAR