PIVOX™ Oblique Lateral Spinal System
GUDID 00643169606579
SPACER 2123440 O25 23.5MM 18 DEG 14X40
MEDTRONIC SOFAMOR DANEK, INC.
Metallic spinal interbody fusion cage| Primary Device ID | 00643169606579 |
| NIH Device Record Key | e69e72d5-d403-4a4d-97ce-e0ced5f7a52f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PIVOX™ Oblique Lateral Spinal System |
| Version Model Number | 2123440 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Angle | 18 degree |
| Angle | 18 degree |
| Angle | 18 degree |
| Angle | 18 degree |
| Angle | 18 degree |
| Angle | 18 degree |
| Angle | 18 degree |
| Angle | 18 degree |
| Length | 40 Millimeter |
| Height | 14 Millimeter |
| Width | 23.5 Millimeter |
| Angle | 18 degree |
| Length | 40 Millimeter |
| Height | 14 Millimeter |
| Width | 23.5 Millimeter |
| Angle | 18 degree |
| Length | 40 Millimeter |
| Height | 14 Millimeter |
| Width | 23.5 Millimeter |
| Angle | 18 degree |
| Length | 40 Millimeter |
| Height | 14 Millimeter |
| Width | 23.5 Millimeter |
| Angle | 18 degree |
| Length | 40 Millimeter |
| Height | 14 Millimeter |
| Width | 23.5 Millimeter |
| Angle | 18 degree |
| Length | 40 Millimeter |
| Height | 14 Millimeter |
| Width | 23.5 Millimeter |
| Angle | 18 degree |
| Length | 40 Millimeter |
| Height | 14 Millimeter |
| Width | 23.5 Millimeter |
| Angle | 18 degree |
| Length | 40 Millimeter |
| Height | 14 Millimeter |
| Width | 23.5 Millimeter |
| Angle | 18 degree |
| Length | 40 Millimeter |
| Height | 14 Millimeter |
| Width | 23.5 Millimeter |
| Angle | 18 degree |
| Length | 40 Millimeter |
| Height | 14 Millimeter |
| Width | 23.5 Millimeter |
| Angle | 18 degree |
| Length | 40 Millimeter |
| Height | 14 Millimeter |
| Width | 23.5 Millimeter |
| Angle | 18 degree |
| Length | 40 Millimeter |
| Height | 14 Millimeter |
| Width | 23.5 Millimeter |
| Angle | 18 degree |
| Length | 40 Millimeter |
| Height | 14 Millimeter |
| Width | 23.5 Millimeter |
| Angle | 18 degree |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169606579 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152277
FDA Product Code
| OVD | Intervertebral fusion device with integrated fixation, lumbar |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-24 |
| 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 |
Trademark Results [PIVOX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PIVOX 86598634 5087447 Live/Registered |
Warsaw Orthopedic, Inc. 2015-04-15 |
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