ANATOMIC PEEK PTC Cervical Fusion System

GUDID 00643169411951

ANATOMIC PEEK PTC X1013044 9X18X16

MEDTRONIC SOFAMOR DANEK, INC.

Polymeric spinal fusion cage, sterile

• Primary Device ID: 00643169411951
• NIH Device Record Key: 98da962b-bf53-4190-b1d2-f65767c3d0f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANATOMIC PEEK PTC Cervical Fusion System
• Version Model Number: X1013044
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169411951 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133653

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

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: 2016-04-03

On-Brand Devices [ANATOMIC PEEK PTC Cervical Fusion System]

• 00643169412002: ANATOMIC PEEK PTC X1013049 14X18X16
• 00643169411999: ANATOMIC PEEK PTC X1013048 13X18X16
• 00643169411982: ANATOMIC PEEK PTC X1013047 12X18X16
• 00643169411975: ANATOMIC PEEK PTC X1013046 11X18X16
• 00643169411968: ANATOMIC PEEK PTC X1013045 10X18X16
• 00643169411951: ANATOMIC PEEK PTC X1013044 9X18X16
• 00643169411944: ANATOMIC PEEK PTC X1013043 8X18X16
• 00643169411937: ANATOMIC PEEK PTC X1013042 7X18X16
• 00643169411920: ANATOMIC PEEK PTC X1013041 6X18X16
• 00643169411913: ANATOMIC PEEK PTC X1013040 5X18X16
• 00643169411906: ANATOMIC PEEK PTC X1013039 14X16X14
• 00643169411890: ANATOMIC PEEK PTC X1013038 13X16X14
• 00643169411883: ANATOMIC PEEK PTC X1013037 12X16X14
• 00643169411876: ANATOMIC PEEK PTC X1013036 11X16X14
• 00643169411869: ANATOMIC PEEK PTC X1013035 10X16X14
• 00643169408036: CAGE 5030386 ANATOMIC PTC 18X16X13MM
• 00643169357709: CAGE 5030441 ANATOMIC PTC 14X11X14MM
• 00643169357686: CAGE 5030341 ANATOMIC PTC 14X11X13MM
• 00643169357655: CAGE 5030241 ANATOMIC PTC 14X11X12MM
• 00643169357624: CAGE 5030141 ANATOMIC PTC 14X11X11MM
• 00643169357600: CAGE 5030064 ANATOMIC PTC 16X14X10MM
• 00643169357594: CAGE 5030041 ANATOMIC PTC 14X11X10MM
• 00643169357587: CAGE 5030541 ANATOMIC PTC 14X11X5MM
• 00643169357570: CAGE 5030564 ANATOMIC PTC 16X14X5MM
• 00643169357556: CAGE 5030641 ANATOMIC PTC 14X11X6MM
• 00643169357549: CAGE 5030664 ANATOMIC PTC 16X14X6MM
• 00643169357525: CAGE 5030741 ANATOMIC PTC 14X11X7MM
• 00643169357518: CAGE 5030764 ANATOMIC PTC 16X14X7MM
• 00643169357495: CAGE 5030841 ANATOMIC PTC 14X11X8MM
• 00643169357488: CAGE 5030864 ANATOMIC PTC 16X14X8MM
• 00643169357464: CAGE 5030941 ANATOMIC PTC 14X11X9MM
• 00643169357457: CAGE 5030964 ANATOMIC PTC 16X14X9MM