PIVOX™ Oblique Lateral Spinal System

GUDID 00643169595545

TRIAL 2191445 O25 IB 27MM 6 DEG 14X45

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial

• Primary Device ID: 00643169595545
• NIH Device Record Key: bac1a4c4-5d07-412b-82eb-f85fadfee03c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PIVOX™ Oblique Lateral Spinal System
• Version Model Number: 2191445
• 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: true
• 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	00643169595545 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152277

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00643169595545]

Moist Heat or Steam Sterilization

[00643169595545]

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: 2016-01-20

On-Brand Devices [PIVOX™ Oblique Lateral Spinal System]

• 00643169654723: SCREW 2140150 LUMBAR BONE 5.5 X 50MM
• 00643169654716: SCREW 2140145 LUMBAR BONE 5.5 X 45MM
• 00643169649620: TRAY 2201005 PIVOX 27MM TRIALS
• 00643169639621: INSERTER 2163000 OLIF25 IB TRIAL INSERTR
• 00643169639614: REMOVER 2162000 OLIF25 INTERBODY REMOVER
• 00643169639607: SHAFT 2161001 OLIF25 INTERBODY THREADED
• 00643169639591: INSERTER 2161000 OLIF25 INTERBODY
• 00643169639584: TRIAL 2143002 OLIF25 PLATE TRIAL LARGE
• 00643169639577: TRIAL 2143001 OLIF25 PLATE TRIAL SMALL
• 00643169639560: INSERTER 2141000 OLIF25 PLATE
• 00643169639553: SHAFT 2140020 OLIF25 PLATE-CAGE CENTER
• 00643169639546: GUIDE 2140012 LRGE PLATE SCREW INSERTION
• 00643169639539: GUIDE 2140011 SMLL PLATE SCREW INSERTION
• 00643169639522: INSERTER 2140010 OLIF25 PLATE-CAGE
• 00643169637528: TRAY 2201004 PIVOX 20MM 12-18 DEG TRIALS
• 00643169634787: SCREW 2140140 LUMBAR BONE 5.5 X 40MM
• 00643169634770: SCREW 2140135 LUMBAR BONE 5.5 X 35MM
• 00643169634763: SCREW 2140130 LUMBAR BONE 5.5 X 30MM
• 00643169634756: SCREW 2140125 LUMBAR BONE 5.5 X 25MM
• 00643169634749: SCREW 2140120 LUMBAR BONE 5.5 X 20MM
• 00643169631533: TRAY 2201002 PIVOX 20MM 6 DEGREE TRIALS
• 00643169631526: TRAY 2201001 PIVOX INSTRUMENT SET 2
• 00643169631519: TRAY 2201000 PIVOX INSTRUMENT SET 1
• 00643169606715: SPACER 2123660 O25 23.5MM 18 DEG 18X60
• 00643169606708: SPACER 2123655 O25 23.5MM 18 DEG 18X55
• 00643169606692: SPACER 2123650 O25 23.5MM 18 DEG 18X50
• 00643169606685: SPACER 2123645 O25 23.5MM 18 DEG 18X45
• 00643169606678: SPACER 2123640 O25 23.5MM 18 DEG 18X40
• 00643169606661: SPACER 2123560 O25 23.5MM 18 DEG 16X60
• 00643169606654: SPACER 2123555 O25 23.5MM 18 DEG 16X55
• 00643169606647: SPACER 2123550 O25 23.5MM 18 DEG 16X50
• 00643169606630: SPACER 2123545 O25 23.5MM 18 DEG 16X45
• 00643169606623: SPACER 2123540 O25 23.5MM 18 DEG 16X40
• 00643169606616: SPACER 2123460 O25 23.5MM 18 DEG 14X60
• 00643169606609: SPACER 2123455 O25 23.5MM 18 DEG 14X55
• 00643169606593: SPACER 2123450 O25 23.5MM 18 DEG 14X50
• 00643169606586: SPACER 2123445 O25 23.5MM 18 DEG 14X45
• 00643169606579: SPACER 2123440 O25 23.5MM 18 DEG 14X40
• 00643169606517: SPACER 2122660 O25 23.5MM 12 DEG 18X60
• 00643169606500: SPACER 2122655 O25 23.5MM 12 DEG 18X55
• 00643169606494: SPACER 2122650 O25 23.5MM 12 DEG 18X50
• 00643169606487: SPACER 2122645 O25 23.5MM 12 DEG 18X45
• 00643169606470: SPACER 2122640 O25 23.5MM 12 DEG 18X40
• 00643169606463: SPACER 2122560 O25 23.5MM 12 DEG 16X60
• 00643169606456: SPACER 2122555 O25 23.5MM 12 DEG 16X55
• 00643169606449: SPACER 2122550 O25 23.5MM 12 DEG 16X50
• 00643169606432: SPACER 2122545 O25 23.5MM 12 DEG 16X45
• 00643169606425: SPACER 2122540 O25 23.5MM 12 DEG 16X40
• 00643169606418: SPACER 2122460 O25 23.5MM 12 DEG 14X60
• 00643169606401: SPACER 2122455 O25 23.5MM 12 DEG 14X55