CLYDESDALE PTC™ Spinal System

GUDID 00643169191112

CAGE 4926255 CDALE PTC 22MM 6 DEG 12X55

MEDTRONIC SOFAMOR DANEK, INC.

Polymeric spinal fusion cage, sterile

• Primary Device ID: 00643169191112
• NIH Device Record Key: 479a064b-6265-4c90-be1c-855f8cb294ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLYDESDALE PTC™ Spinal System
• Version Model Number: 4926255
• 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: false
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00643169191112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133205

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

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: 2016-04-17

On-Brand Devices [CLYDESDALE PTC™ Spinal System]

• 00643169191358: CAGE 4922060 CDALE PTC 22MM 12 DEG 10X60
• 00643169191341: CAGE 4922240 CDALE PTC 22MM 12 DEG 12X40
• 00643169191334: CAGE 4922245 CDALE PTC 22MM 12 DEG 12X45
• 00643169191327: CAGE 4922250 CDALE PTC 22MM 12 DEG 12X50
• 00643169191310: CAGE 4922255 CDALE PTC 22MM 12 DEG 12X55
• 00643169191303: CAGE 4922260 CDALE PTC 22MM 12 DEG 12X60
• 00643169191297: CAGE 4922440 CDALE PTC 22MM 12 DEG 14X40
• 00643169191280: CAGE 4922445 CDALE PTC 22MM 12 DEG 14X45
• 00643169191273: CAGE 4922450 CDALE PTC 22MM 12 DEG 14X50
• 00643169191266: CAGE 4922455 CDALE PTC 22MM 12 DEG 14X55
• 00643169191259: CAGE 4922460 CDALE PTC 22MM 12 DEG 14X60
• 00643169191242: CAGE 4922640 CDALE PTC 22MM 12 DEG 16X40
• 00643169191235: CAGE 4922645 CDALE PTC 22MM 12 DEG 16X45
• 00643169191228: CAGE 4922650 CDALE PTC 22MM 12 DEG 16X50
• 00643169191211: CAGE 4922655 CDALE PTC 22MM 12 DEG 16X55
• 00643169191204: CAGE 4922660 CDALE PTC 22MM 12 DEG 16X60
• 00643169191198: CAGE 4926040 CDALE PTC 22MM 6 DEG 10X40
• 00643169191181: CAGE 4926045 CDALE PTC 22MM 6 DEG 10X45
• 00643169191174: CAGE 4926050 CDALE PTC 22MM 6 DEG 10X50
• 00643169191167: CAGE 4926055 CDALE PTC 22MM 6 DEG 10X55
• 00643169191150: CAGE 4926060 CDALE PTC 22MM 6 DEG 10X60
• 00643169191143: CAGE 4926240 CDALE PTC 22MM 6 DEG 12X40
• 00643169191136: CAGE 4926245 CDALE PTC 22MM 6 DEG 12X45
• 00643169191129: CAGE 4926250 CDALE PTC 22MM 6 DEG 12X50
• 00643169191112: CAGE 4926255 CDALE PTC 22MM 6 DEG 12X55
• 00643169191105: CAGE 4926260 CDALE PTC 22MM 6 DEG 12X60
• 00643169191099: CAGE 4926440 CDALE PTC 22MM 6 DEG 14X40
• 00643169191082: CAGE 4926445 CDALE PTC 22MM 6 DEG 14X45
• 00643169191075: CAGE 4922055 CDALE PTC 22MM 12 DEG 10X55
• 00643169191068: CAGE 4920040 CDALE PTC 22MM 0 DEG 10X40
• 00643169191051: CAGE 4920045 CDALE PTC 22MM 0 DEG 10X45
• 00643169191044: CAGE 4920050 CDALE PTC 22MM 0 DEG 10X50
• 00643169191037: CAGE 4920055 CDALE PTC 22MM 0 DEG 10X55
• 00643169191020: CAGE 4920060 CDALE PTC 22MM 0 DEG 10X60
• 00643169191013: CAGE 4920240 CDALE PTC 22MM 0 DEG 12X40
• 00643169191006: CAGE 4920245 CDALE PTC 22MM 0 DEG 12X45
• 00643169190993: CAGE 4920250 CDALE PTC 22MM 0 DEG 12X50
• 00643169190986: CAGE 4920255 CDALE PTC 22MM 0 DEG 12X55
• 00643169190979: CAGE 4920260 CDALE PTC 22MM 0 DEG 12X60
• 00643169190962: CAGE 4920440 CDALE PTC 22MM 0 DEG 14X40
• 00643169190955: CAGE 4920445 CDALE PTC 22MM 0 DEG 14X45
• 00643169190948: CAGE 4920450 CDALE PTC 22MM 0 DEG 14X50
• 00643169190931: CAGE 4920455 CDALE PTC 22MM 0 DEG 14X55
• 00643169190924: CAGE 4920460 CDALE PTC 22MM 0 DEG 14X60
• 00643169190917: CAGE 4920640 CDALE PTC 22MM 0 DEG 16X40
• 00643169190900: CAGE 4920645 CDALE PTC 22MM 0 DEG 16X45
• 00643169190894: CAGE 4920650 CDALE PTC 22MM 0 DEG 16X50
• 00643169190887: CAGE 4920655 CDALE PTC 22MM 0 DEG 16X55
• 00643169190870: CAGE 4920660 CDALE PTC 22MM 0 DEG 16X60
• 00643169190863: CAGE 4920840 CDALE PTC 22MM 0 DEG 8X40