CD HORIZON® Growth Rod Conversion Set

GUDID 00643169500556

CONNECTOR 811188GR 70MM TI 4.5MM ROD S

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 00643169500556
• NIH Device Record Key: 892c7c27-7e43-4250-a8c4-c0f7e2b3463b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CD HORIZON® Growth Rod Conversion Set
• Version Model Number: 811188GR
• 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
• 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 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	00643169500556 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150200

FDA Product Code

• PGM: Growing rod system

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: 2016-03-16

On-Brand Devices [CD HORIZON® Growth Rod Conversion Set]

• 00643169500709: CONNECTOR 811173GR 40MM SS 3.5MM ROD S
• 00643169500686: CONNECTOR 811175GR 50MM SS 3.5MM ROD S
• 00643169500679: CONNECTOR 811176GR 50MM TI 3.5MM ROD S
• 00643169500662: CONNECTOR 811177GR 70MM SS 3.5MM ROD S
• 00643169500655: CONNECTOR 811178GR 70MM TI 3.5MM ROD S
• 00643169500648: CONNECTOR 811179GR 90MM SS 3.5MM ROD S
• 00643169500631: CONNECTOR 811180GR 90MM TI 3.5MM ROD S
• 00643169500624: CONNECTOR 811181GR 110MM SS 3.5MM ROD S
• 00643169500600: CONNECTOR 811183GR 40MM SS 4.5MM ROD S
• 00643169500594: CONNECTOR 811184GR 40MM TI 4.5MM ROD S
• 00643169500587: CONNECTOR 811185GR 50MM SS 4.5MM ROD S
• 00643169500570: CONNECTOR 811186GR 50MM TI 4.5MM ROD S
• 00643169500563: CONNECTOR 811187GR 70MM SS 4.5MM ROD S
• 00643169500556: CONNECTOR 811188GR 70MM TI 4.5MM ROD S
• 00643169500549: CONNECTOR 811189GR 90MM SS 4.5MM ROD S
• 00643169500532: CONNECTOR 811190GR 90MM TI 4.5MM ROD S
• 00643169500525: CONNECTOR 811191GR 110MM SS 4.5MM ROD S
• 00643169500518: CONNECTOR 811192GR 110MM TI 4.5MM ROD S
• 00643169500501: CONNECTOR 811194GR 40MM TI 4.75MM ROD S
• 00643169500495: CONNECTOR 811196GR 50MM TI 4.75MM ROD S
• 00643169500488: CONNECTOR 811198GR 70MM TI 4.75MM ROD S
• 00643169500471: CONNECTOR 811200GR 90MM TI 4.75MM ROD S
• 00643169500464: CONNECTOR 811202GR 110MM TI 4.75MM ROD S
• 00643169500457: CONNECTOR 811203GR 40MM SS 5.5MM ROD S
• 00643169500433: CONNECTOR 811205GR 50MM SS 5.5MM ROD S
• 00643169500426: CONNECTOR 811206GR 50MM TI 5.5MM ROD S
• 00643169500419: CONNECTOR 811207GR 70MM SS 5.5MM ROD S
• 00643169500402: CONNECTOR 811208GR 70MM TI 5.5MM ROD S
• 00643169500396: CONNECTOR 811209GR 90MM SS 5.5MM ROD S
• 00643169500389: CONNECTOR 811210GR 90MM TI 5.5MM ROD S
• 00643169500372: CONNECTOR 811211GR 110MM SS 5.5MM ROD S
• 20643169545629: SET SCREW 7360000GR SS BREAK-OFF S