ZEVO™ Anterior Cervical Plate System

GUDID 00643169329546

PLATE 3003065 ZEVO 65MM 3 LVL

MEDTRONIC SOFAMOR DANEK, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00643169329546
• NIH Device Record Key: 54558173-4218-43e2-a176-30f7219c45d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZEVO™ Anterior Cervical Plate System
• Version Model Number: 3003065
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169329546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141632

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00643169329546]

Moist Heat or Steam Sterilization

[00643169329546]

Moist Heat or Steam Sterilization

[00643169329546]

Moist Heat or Steam Sterilization

[00643169329546]

Moist Heat or Steam Sterilization

[00643169329546]

Moist Heat or Steam Sterilization

[00643169329546]

Moist Heat or Steam Sterilization

[00643169329546]

Moist Heat or Steam Sterilization

[00643169329546]

Moist Heat or Steam Sterilization

[00643169329546]

Moist Heat or Steam Sterilization

[00643169329546]

Moist Heat or Steam Sterilization

[00643169329546]

Moist Heat or Steam Sterilization

[00643169329546]

Moist Heat or Steam Sterilization

[00643169329546]

Moist Heat or Steam Sterilization

[00643169329546]

Moist Heat or Steam Sterilization

[00643169329546]

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: 2015-10-16

On-Brand Devices [ZEVO™ Anterior Cervical Plate System]

• 00613994404947: LID 1850079 GENERIC OUTER LID
• 00643169630109: CADDY 3036017R ZEVO ST SCREWS CADDY
• 00643169630093: CADDY 3036015R ZEVO SD SCREWS CADDY
• 00643169404090: SCREW G7714010 ZEVO VAR SD 4.0MM X 10MM
• 00643169398726: SCREW G7703518 ZEVO VAR SD 3.5MM X 18MM
• 00643169398719: SCREW G7703519 ZEVO VAR SD 3.5MM X 19MM
• 00643169398702: SCREW G7703520 ZEVO VAR SD 3.5MM X 20MM
• 00643169398696: SCREW G7703521 ZEVO VAR SD 3.5MM X 21MM
• 00643169398689: SCREW G7703522 ZEVO VAR SD 3.5MM X 22MM
• 00643169398672: SCREW G7703523 ZEVO VAR SD 3.5MM X 23MM
• 00643169398665: SCREW G7703524 ZEVO VAR SD 3.5MM X 24MM
• 00643169398658: SCREW G7783510 ZEVO VAR ST 3.5MM X 10MM
• 00643169398641: SCREW G7783511 ZEVO VAR ST 3.5MM X 11MM
• 00643169398634: SCREW G7783512 ZEVO VAR ST 3.5MM X 12MM
• 00643169398627: SCREW G7783513 ZEVO VAR ST 3.5MM X 13MM
• 00643169398610: SCREW G7783514 ZEVO VAR ST 3.5MM X 14MM
• 00643169398603: SCREW G7783515 ZEVO VAR ST 3.5MM X 15MM
• 00643169398597: SCREW G7783516 ZEVO VAR ST 3.5MM X 16MM
• 00643169398580: SCREW G7783517 ZEVO VAR ST 3.5MM X 17MM
• 00643169398573: SCREW G7783518 ZEVO VAR ST 3.5MM X 18MM
• 00643169398566: SCREW G7783519 ZEVO VAR ST 3.5MM X 19MM
• 00643169398559: SCREW G7783520 ZEVO VAR ST 3.5MM X 20MM
• 00643169398542: SCREW G7783521 ZEVO VAR ST 3.5MM X 21MM
• 00643169398535: SCREW G7703510 ZEVO VAR SD 3.5MM X 10MM
• 00643169398528: SCREW G7703511 ZEVO VAR SD 3.5MM X 11MM
• 00643169398511: SCREW G7703512 ZEVO VAR SD 3.5MM X 12MM
• 00643169398504: SCREW G7703513 ZEVO VAR SD 3.5MM X 13MM
• 00643169398498: SCREW G7703514 ZEVO VAR SD 3.5MM X 14MM
• 00643169398481: SCREW G7703515 ZEVO VAR SD 3.5MM X 15MM
• 00643169398474: SCREW G7703516 ZEVO VAR SD 3.5MM X 16MM
• 00643169398467: SCREW G7703517 ZEVO VAR SD 3.5MM X 17MM
• 00643169398450: SCREW G7783524 ZEVO VAR ST 3.5MM X 24MM
• 00643169398443: SCREW G7783523 ZEVO VAR ST 3.5MM X 23MM
• 00643169398436: SCREW G7783522 ZEVO VAR ST 3.5MM X 22MM
• 00643169368958: PLATE 3005090 ZEVO 90MM 5 LVL
• 00643169368941: PLATE G3005090 ZEVO 90MM 5 LVL
• 00643169348509: PLATE 3004086 ZEVO 86MM 4 LVL
• 00643169348493: PLATE 3004078 ZEVO 78MM 4 LVL
• 00643169348486: PLATE 3003068 ZEVO 68MM 3 LVL
• 00643169348479: PLATE 3003048 ZEVO 48MM 3 LVL
• 00643169348462: PLATE 3002048 ZEVO 48MM 2 LVL
• 00643169347922: PLATE G3004086 ZEVO 86MM 4 LVL
• 00643169347915: PLATE G3004078 ZEVO 78MM 4 LVL
• 00643169347908: PLATE G3003068 ZEVO 68MM 3 LVL
• 00643169347892: PLATE G3003048 ZEVO 48MM 3 LVL
• 00643169347885: PLATE G3002048 ZEVO 48MM 2 LVL
• 00643169343573: TRAY 3036001 ZEVO DEGEN SET LOWER
• 00643169343559: TRAY 3036003 ZEVO INSTR SET
• 00643169343542: CADDY 3036004 ZEVO PLATE HOLD PIN SET
• 00643169343535: LID 3036005 ZEVO PLATE HOLD PIN SET