CD HORIZON® SOLERA® Spinal System

GUDID 00643169280816

TRAY 7068589 CDHS 5.5/6.0 CANN SAS LOWER

MEDTRONIC SOFAMOR DANEK, INC.

Instrument tray, reusable

• Primary Device ID: 00643169280816
• NIH Device Record Key: 55e9babb-5fc8-49bc-955d-73bd5b81ae2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CD HORIZON® SOLERA® Spinal System
• Version Model Number: 7068589
• 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
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00643169280816 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190840

FDA Product Code

• FSM: TRAY, SURGICAL, INSTRUMENT

Sterilization

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

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

[00643169280816]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-08
• Device Publish Date: 2021-02-28

On-Brand Devices [CD HORIZON® SOLERA® Spinal System]

• 00643169976566: ROD X0415073 DUAL BEND 6.0 CCM PLS X 490
• 00643169976559: ROD X0415072 DUAL BEND 6.0 CCM PLS L 400
• 00643169976542: ROD X0415071 DUAL BEND 6.0 CCM PLS S 350
• 00643169841529: TRANS HOOK X0516107 30 DEG-NRW-SML-L
• 00643169841512: TRANS HOOK X0516106 30 DEG-NRW-SML-R
• 00643169841505: TRANS HOOK X0516105 30 DEG-NRW-MED-L
• 00643169841499: TRANS HOOK X0516104 30 DEG-NRW-MED-R
• 00643169841482: TRANS HOOK X0516103 30 DEG-NRW-LRG-L
• 00643169841475: TRANS HOOK X0516102 30 DEG-NRW-LRG-R
• 00643169841468: TRANS HOOK X0516101 45 DEG-NRW-SML-L
• 00643169841451: TRANS HOOK X0516100 45 DEG-NRW-SML-R
• 00643169841444: TRANS HOOK X0516099 45 DEG-NRW-MED-L
• 00643169841437: TRANS HOOK X0516098 45 DEG-NRW-MED-R
• 00643169841420: TRANS HOOK X0516097 45 DEG-NRW-LRG-L
• 00643169841413: TRANS HOOK X0516096 45 DEG-NRW-LRG-R
• 00643169841406: TRANS HOOK X0516095 30 DEG-WIDE-SML-L
• 00643169841390: TRANS HOOK X0516094 30 DEG-WIDE-SML-R
• 00643169841383: TRANS HOOK X0516093 30 DEG-WIDE-MED-L
• 00643169841376: TRANS HOOK X0516092 30 DEG-WIDE-MED-R
• 00643169841369: TRANS HOOK X0516091 30 DEG-WIDE-LRG-L
• 00643169841352: TRANS HOOK X0516090 30 DEG-WIDE-LRG-R
• 00643169841345: TRANS HOOK X0516048 45 DEG-WIDE-SML-L
• 00643169841338: TRANS HOOK X0516047 45 DEG-WIDE-SML-R
• 00643169841321: TRANS HOOK X0516046 45 DEG-WIDE-MED-L
• 00643169841314: TRANS HOOK X0516045 45 DEG-WIDE-MED-R
• 00643169841307: TRANS HOOK X0316003 45 DEG-WIDE-LRG-L
• 00643169841291: TRANS HOOK X0316002 45 DEG-WIDE-LRG-R
• 00643169834309: SCREW 55840047560 5.5SOLERAMAS-ATS7.5X60
• 00643169834293: SCREW 55840047555 5.5SOLERAMAS-ATS7.5X55
• 00643169834286: SCREW 55840047550 5.5SOLERAMAS-ATS7.5X50
• 00643169834279: SCREW 55840047545 5.5SOLERAMAS-ATS7.5X45
• 00643169834262: SCREW 55840047540 5.5SOLERAMAS-ATS7.5X40
• 00643169834255: SCREW 55840047535 5.5SOLERAMAS-ATS7.5X35
• 00643169834248: SCREW 55840047530 5.5SOLERAMAS-ATS7.5X30
• 00643169834231: SCREW 55840047525 5.5SOLERAMAS-ATS7.5X25
• 00643169834224: SCREW 55840047520 5.5SOLERAMAS-ATS7.5X20
• 00643169834217: SCREW 55840046560 5.5SOLERAMAS-ATS6.5X60
• 00643169834200: SCREW 55840046555 5.5SOLERAMAS-ATS6.5X55
• 00643169834194: SCREW 55840046550 5.5SOLERAMAS-ATS6.5X50
• 00643169834187: SCREW 55840046545 5.5SOLERAMAS-ATS6.5X45
• 00643169834170: SCREW 55840046540 5.5SOLERAMAS-ATS6.5X40
• 00643169834163: SCREW 55840046535 5.5SOLERAMAS-ATS6.5X35
• 00643169834156: SCREW 55840046530 5.5SOLERAMAS-ATS6.5X30
• 00643169834149: SCREW 55840046525 5.5SOLERAMAS-ATS6.5X25
• 00643169834132: SCREW 55840046520 5.5SOLERAMAS-ATS6.5X20
• 00643169834125: SCREW 55840045560 5.5SOLERAMAS-ATS5.5X60
• 00643169834118: SCREW 55840045555 5.5SOLERAMAS-ATS5.5X55
• 00643169834101: SCREW 55840045550 5.5SOLERAMAS-ATS5.5X50
• 00643169834095: SCREW 55840045545 5.5SOLERAMAS-ATS5.5X45
• 00643169834088: SCREW 55840045540 5.5SOLERAMAS-ATS5.5X40