ANATOMIC PEEK PTC Cervical Fusion System

GUDID 00643169411876

ANATOMIC PEEK PTC X1013036 11X16X14

MEDTRONIC SOFAMOR DANEK, INC.

Polymeric spinal fusion cage, sterile Polymeric spinal fusion cage, sterile Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage

• Primary Device ID: 00643169411876
• NIH Device Record Key: 1d705d2c-36fc-4926-bcba-3b326fcecde8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANATOMIC PEEK PTC Cervical Fusion System
• Version Model Number: X1013036
• 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	00643169411876 [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