VERTEX® Reconstruction System

GUDID 00643169101463

ROD G7753870 PRE-CUT 3.5MM X 70MM CCM

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00643169101463
• NIH Device Record Key: d59e60aa-1f31-4019-8fa7-d45b107cd4b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERTEX® Reconstruction System
• Version Model Number: G7753870
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169101463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180851

FDA Product Code

• NKG: Orthosis, cervical pedicle screw spinal fixation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-03
• Device Publish Date: 2018-08-02

On-Brand Devices [VERTEX® Reconstruction System]

• 00613994932433: Connector 7753619 Open Lateral 19mm
• 00613994901187: X LINK X0710382 VER SEL MAS XS 26/30MM
• 00613994763716: PLATE X0310008 VER OC ADJUSTABLE SM
• 00613994738127: SCR X0909575 VER TI CORT BLNTTIP 4.0X6
• 00613994738110: SCR X0909576 VER TI CORT BLNTTIP 4.0X8
• 00613994738103: SCR X0909577 VER TI CORT BLNTTIP 4.0X10
• 00613994738097: SCR X0909578 VER TI CORT BLNTTIP 4.0X12
• 00613994738080: SCR X0909579 VER TI CORT BLNTTIP 4.0X14
• 00613994738073: SCR X0909580 VER TI CORT BLNTTIP 4.0X16
• 00613994738066: SCR X0909581 VER TI CORT BLNTTIP 4.0X18
• 00613994738059: SCR X0909582 VER TI CORT BLNTTIP 4.5X6
• 00613994738042: SCR X0909583 VER TI CORT BLNTTIP 4.5X8
• 00613994738035: SCR X0909584 VER TI CORT BLNTTIP 4.5X10
• 00613994738028: SCR X0909585 VER TI CORT BLNTTIP 4.5X12
• 00613994738011: SCR X0909586 VER TI CORT BLNTTIP 4.5X14
• 00613994738004: SCR X0909587 VER TI CORT BLNTTIP 4.5X16
• 00613994737991: SCR X0909588 VER TI CORT BLNTTIP 4.5X18
• 00613994737984: SCR X0909589 VER TI CORT BLNTTIP 5.0X6
• 00613994737977: SCR X0909590 VER TI CORT BLNTTIP 5.0X8
• 00613994737960: SCR X0909591 VER TI CORT BLNTTIP 5.0X10
• 00613994737953: SCR X0909592 VER TI CORT BLNTTIP 5.0X12
• 00613994737946: SCR X0909593 VER TI CORT BLNTTIP 5.0X14
• 00613994737939: SCR X0909594 VER TI CORT BLNTTIP 5.0X16
• 00613994737922: SCR X0909595 VER TI CORT BLNTTIP 5.0X18
• 00613994718266: TRAY 7757258 INSTRUMENT 2 OF 4
• 00613994667373: SCREW G7750518 OC SCREW 4.5 X 18MM
• 00613994667335: SCREW G7750606 OC SCREW 5.0 X 6MM
• 00613994667328: SCREW G7750608 OC SCREW 5.0 X 8MM
• 00613994667311: SCREW G7750610 OC SCREW 5.0 X 10MM
• 00613994667304: SCREW G7750612 OC SCREW 5.0 X 12MM
• 00613994667298: SCREW G7750614 OC SCREW 5.0 X 14MM
• 00613994667281: SCREW G7750616 OC SCREW 5.0 X 16MM
• 00613994667274: SCREW G7750618 OC SCREW 5.0 X 18MM
• 00613994667199: ROD G7755124 ADJ ROD 3.5MM X 220MM
• 00613994667052: SCREW G7750506 OC SCREW 4.5 X 6MM
• 00613994667045: SCREW G7750508 OC SCREW 4.5 X 8MM
• 00613994667038: SCREW G7750510 OC SCREW 4.5 X 10MM
• 00613994667021: SCREW G7750512 OC SCREW 4.5 X 12MM
• 00613994667014: SCREW G7750514 OC SCREW 4.5 X 14MM
• 00613994667007: SCREW G7750516 OC SCREW 4.5 X 16MM
• 00613994666949: PLATE G7755278 OC MIDLINE TRANSLATIONAL
• 00613994666918: CONNECTOR G7755325 LP OC SCREW CONNECTOR
• 00613994666901: CONNECTOR G7755327 OFFSET LP OC SCREW CO
• 00613994666833: PLATE G7759970 LP OC MIDLINE M-SHAPED S
• 00613994666826: PLATE G7759971 LP OC MIDLINE M-SHAPED M
• 00613994666819: PLATE G7759972 LP OC MIDLINE M-SHAPED L
• 00613994666635: ROD G7755271 PRE-BENT 3.5 X 200MM
• 00613994641915: ROD G7750088 COBALT CHROME 3.5 X 300MM
• 00613994597601: CONNECTOR X1108073 LAT TI 45DEG 13MM 3.5
• 00613994578143: ROD X0209552 TI 3.2 X 20MM