Crescent Spinal System Titanium

GUDID 00613994907707

TRIAL 9503009 09MMX30MM ANG

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial

• Primary Device ID: 00613994907707
• NIH Device Record Key: 49e15fde-6326-4a91-a294-7f4fe9653267
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Crescent Spinal System Titanium
• Version Model Number: 9503009
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00613994907707 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110543

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00613994907707]

Moist Heat or Steam Sterilization

[00613994907707]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2015-09-09

On-Brand Devices [Crescent Spinal System Titanium]

• 00613994907936: TRIAL 9501630 16MMX30MM STR
• 00613994907929: TRIAL 9501530 15MMX30MM STR
• 00613994907912: TRIAL 9501430 14MMX30MM STR
• 00613994907905: TRIAL 9501330 13MMX30MM STR
• 00613994907899: TRIAL 9501230 12MMX30MM STR
• 00613994907882: TRIAL 9501130 11MMX30MM STR
• 00613994907875: TRIAL 9501030 10MMX30MM STR
• 00613994907868: TRIAL 9500930 09MMX30MM STR
• 00613994907851: TRIAL 9500830 08MMX30MM STR
• 00613994907844: TRIAL 9500730 07MMX30MM STR
• 00613994907776: TRIAL 9503016 16MMX30MM ANG
• 00613994907769: TRIAL 9503015 15MMX30MM ANG
• 00613994907752: TRIAL 9503014 14MMX30MM ANG
• 00613994907745: TRIAL 9503013 13MMX30MM ANG
• 00613994907738: TRIAL 9503012 12MMX30MM ANG
• 00613994907721: TRIAL 9503011 11MMX30MM ANG
• 00613994907714: TRIAL 9503010 10MMX30MM ANG
• 00613994907707: TRIAL 9503009 09MMX30MM ANG
• 00613994907691: TRIAL 9503008 08MMX30MM ANG
• 00613994907684: TRIAL 9503007 07MMX30MM ANG
• 00613994898111: INSERTER 6660004 SHAFT
• 00613994880239: SPACER X0310662 CRESCENT PK TAPERED 25X7
• 00613994880222: SPACER X0310663 CRESCENT PK TAPERED 25X8
• 00613994880215: SPACER X0310664 CRESCENT PK TAPERED 25X9
• 00613994880208: SPACER X0310665 CRESCENT PK TAPERD 25X10
• 00613994880192: SPACER X0310666 CRESCENT PK TAPERD 25X11
• 00613994880185: SPACER X0310667 CRESCENT PK TAPERD 25X12
• 00613994880178: SPACER X0310668 CRESCENT PK TAPERD 25X13
• 00613994880161: SPACER X0310669 CRESCENT PK TAPERD 25X14
• 00613994880154: SPACER X0310670 CRESCENT PK TAPERD 25X15
• 00613994880147: SPACER X0610001 CRESCENT PK TAPERED 30X7
• 00613994880130: SPACER X0610002 CRESCENT PK TAPERED 30X8
• 00613994880123: SPACER X0610003 CRESCENT PK TAPERED 30X9
• 00613994880116: SPACER X0610004 CRESCENT PK TAPERD 30X10
• 00613994880109: SPACER X0610005 CRESCENT PK TAPERD 30X11
• 00613994880093: SPACER X0610006 CRESCENT PK TAPERD 30X12
• 00613994880086: SPACER X0610007 CRESCENT PK TAPERD 30X13
• 00613994880079: SPACER X0610008 CRESCENT PK TAPERD 30X14
• 00613994880062: SPACER X0610009 CRESCENT PK TAPERD 30X15
• 00613994849502: SPACER 6670725 CRESCENT TI WD 07MMX25MM
• 00613994849496: SPACER 6670730 CRESCENT TI WD 07MMX30MM
• 00613994849489: SPACER 6670736 CRESCENT TI WD 07MMX36MM
• 00613994849472: SPACER 6670825 CRESCENT TI WD 08MMX25MM
• 00613994849465: SPACER 6670830 CRESCENT TI WD 08MMX30MM
• 00613994849458: SPACER 6670836 CRESCENT TI WD 08MMX36MM
• 00613994849441: SPACER 6670925 CRESCENT TI WD 09MMX25MM
• 00613994849434: SPACER 6670930 CRESCENT TI WD 09MMX30MM
• 00613994849427: SPACER 6670936 CRESCENT TI WD 09MMX36MM
• 00613994849410: SPACER 6671025 CRESCENT TI WD 10MMX25MM
• 00613994849403: SPACER 6671030 CRESCENT TI WD 10MMX30MM