TENOR® SPINAL SYSTEM

GUDID 00673978037103

CLAMP 806PA55T MONOBLOC

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00673978037103
• NIH Device Record Key: 28473c41-12bd-46cc-be29-55d7a35a0adc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TENOR® SPINAL SYSTEM
• Version Model Number: 806PA55T
• 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
• 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	00673978037103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982490

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00673978037103]

Moist Heat or Steam Sterilization

[00673978037103]

Moist Heat or Steam Sterilization

[00673978037103]

Moist Heat or Steam Sterilization

[00673978037103]

Moist Heat or Steam Sterilization

[00673978037103]

Moist Heat or Steam Sterilization

[00673978037103]

Moist Heat or Steam Sterilization

[00673978037103]

Moist Heat or Steam Sterilization

[00673978037103]

Moist Heat or Steam Sterilization

[00673978037103]

Moist Heat or Steam Sterilization

[00673978037103]

Moist Heat or Steam Sterilization

[00673978037103]

Moist Heat or Steam Sterilization

[00673978037103]

Moist Heat or Steam Sterilization

[00673978037103]

Moist Heat or Steam Sterilization

[00673978037103]

Moist Heat or Steam Sterilization

[00673978037103]

Moist Heat or Steam Sterilization

[00673978037103]

Moist Heat or Steam Sterilization

[00673978037103]

Moist Heat or Steam Sterilization

[00673978037103]

Moist Heat or Steam Sterilization

[00673978037103]

Moist Heat or Steam Sterilization

[00673978037103]

Moist Heat or Steam Sterilization

[00673978037103]

Moist Heat or Steam Sterilization

[00673978037103]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-21

On-Brand Devices [TENOR® SPINAL SYSTEM]

• 00681490881753: ROD 806TS55L170T TNR 1.2 D5.5X170MM
• 00681490881746: ROD 806TS55L130T TNR 1.2 5.5X130MM
• 00673978971070: SCREW 806VA55T SET FOR CLSD CLAMP
• 00673978971063: ROD 806TS55L230T TNR 1.2 5.5 X230MM
• 00673978971056: ROD 806TS55L210T TNR 1.2 D5.5MM
• 00673978971049: ROD 806TS55L190T TNR 1.2 5.5X190MM
• 00673978971032: ROD 806TS55L150T TNR 1.2 5.5X150MM
• 00673978037288: ROD 806TS55L90T TNR 1.2 D 5.5X90MM
• 00673978037271: ROD 806TS55L80T TNR 5.5X80MM
• 00673978037264: ROD 806TS55L70T TNR 1.2 5.5X70MM
• 00673978037257: ROD 806TS55L60T TNR 5.5X60MM
• 00673978037240: ROD 806TS55L50T TNR 1.2 5.5X50MM
• 00673978037233: ROD 806TS55L40T TNR 5.5X40MM
• 00673978037226: ROD 806TS55L240T TNR 1.2 D5.5 L240MM
• 00673978037219: ROD 806TS55L220T TNR 1.2 D5.5 L220MM
• 00673978037202: ROD 806TS55L200T TNR 1.2 D5.5 L200MM
• 00673978037196: ROD 806TS55L180T TNR MOD GDLH 5.5X180
• 00673978037189: ROD 806TS55L160T TNR MOD GDLH 5.5X160
• 00673978037172: ROD 806TS55L140T TNR MOD GDLH 5.5X140
• 00673978037165: ROD 806TS55L120T TNR MOD GDLH 5.5X120
• 00673978037158: ROD 806TS55L110T TNR 5.5X110MM
• 00673978037141: ROD 806TS55L100T TNR 5.5X100MM
• 00673978037134: CLAMP 806PS55T CLAMPS FOR 5.5MM ROD
• 00673978037127: CLAMP 806PR55T OFFSET CLAMP
• 00673978037110: CONNECTOR 806PC55T CLOSED
• 00673978037103: CLAMP 806PA55T MONOBLOC
• 00673978037097: CROSSLINK 806LT55L80T TRNSVR W 80MM BAR
• 00673978037080: CROSSLINK 806LT55L60T TRNSVR W 60MM BAR
• 00673978037073: CROSSLINK 806LT55L40T TRNSVR W 40MM BAR
• 00673978037066: CROSSLINK 806LT55L100T TRNSVR W 100MM BA
• 00673978037059: NUT 806ECT SELF BREAKING