obelisc™ vertebral body replacement CS 2925-00
GUDID 04052536013425
obelisc end piece, grey, Ø 20 mm, angle 0°
Ulrich GmbH & Co. KG
Vertebral body prosthesis, non-sterile| Primary Device ID | 04052536013425 |
| NIH Device Record Key | 383de5f7-0550-4872-a934-8594e4310a20 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | obelisc™ vertebral body replacement |
| Version Model Number | CS 2925-00 |
| Catalog Number | CS 2925-00 |
| Company DUNS | 315494757 |
| Company Name | Ulrich GmbH & Co. KG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04052536013425 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K060416
FDA Product Code
| MQP | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
Moist Heat or Steam Sterilization
[04052536013425]
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 | 2016-07-30 |
On-Brand Devices [obelisc™ vertebral body replacement]
| 04052536113699 | obelisc locking screw short, hex 3.5 mm |
| 04052536013661 | obelisc end piece, bronze, oval, 32x26 mm, angle 20° |
| 04052536013654 | obelisc end piece, bronze, oval, 32x26 mm, angle 15° |
| 04052536013647 | obelisc end piece, bronze, oval, 32x26 mm, angle 10° |
| 04052536013630 | obelisc end piece, bronze, oval, 32x26 mm, angle 5° |
| 04052536013623 | obelisc end piece, bronze, oval, 32x26 mm, angle 0° |
| 04052536013616 | obelisc end piece, blue, Ø 32 mm, angle 15° |
| 04052536013609 | obelisc end piece, blue, Ø 32 mm, angle 10° |
| 04052536013593 | obelisc end piece, blue, Ø 32 mm, angle 5° |
| 04052536013586 | obelisc end piece, blue, Ø 32 mm, angle 0° |
| 04052536013579 | obelisc end piece, green, Ø 29 mm, angle 15° |
| 04052536013562 | obelisc end piece, green, Ø 29 mm, angle 10° |
| 04052536013555 | obelisc end piece, green, Ø 29 mm, angle 5° |
| 04052536013548 | obelisc end piece, green, Ø 29 mm, angle 0° |
| 04052536013531 | obelisc end piece, yellow, Ø 26 mm, angle 15° |
| 04052536013524 | obelisc end piece, yellow, Ø 26 mm, angle 10° |
| 04052536013517 | obelisc end piece, yellow, Ø 26 mm, angle 5° |
| 04052536013500 | obelisc end piece, yellow, Ø 26 mm, angle 0° |
| 04052536013494 | obelisc end piece, light blue, Ø 24 mm, angle 15° |
| 04052536013487 | obelisc end piece, light blue, Ø 24 mm, angle 10° |
| 04052536013470 | obelisc end piece, light blue, Ø 24 mm, angle 5° |
| 04052536013463 | obelisc end piece, light blue, Ø 24 mm, angle 0° |
| 04052536013456 | obelisc end piece, grey, Ø 20 mm, angle 15° |
| 04052536013449 | obelisc end piece, grey, Ø 20 mm, angle 10° |
| 04052536013432 | obelisc end piece, grey, Ø 20 mm, angle 5° |
| 04052536013425 | obelisc end piece, grey, Ø 20 mm, angle 0° |
| 04052536013418 | obelisc center piece, Ø 20 mm, height 27-38 mm two variable end pieces |
| 04052536013401 | obelisc center piece, ø 20 mm, height 23-31 mm two variable end pieces |
| 04052536013395 | obelisc center piece, ø 20 mm, height 17-23 mm two fix end pieces |
| 04052536013388 | Spring for obelisc end piece |
| 04052536005727 | obelisc end piece, oval, 32 x 26 mm, angle 15° |
| 04052536005710 | obelisc end piece, Ø 26 mm, angle 10° |
| 04052536005703 | obelisc end piece, Ø 26 mm, angle 5° |
| 04052536005697 | obelisc end piece, Ø 26 mm, angle 0° |
| 04052536005680 | obelisc end piece, Ø 24 mm, angle 10° |
| 04052536005673 | obelisc end piece, Ø 24 mm, angle 5° |
| 04052536005666 | obelisc end piece, Ø 24 mm, angle 0° |
| 04052536005659 | obelisc end piece, Ø 20 mm, angle 10° |
| 04052536005642 | obelisc end piece, Ø 20 mm, angle 5° |
| 04052536005635 | obelisc end piece, Ø 20 mm, angle 0° |
| 04052536005628 | obelisc center piece, ø 20 mm, height 76-132 mm two variable end pieces |
| 04052536005611 | obelisc center piece, ø 20 mm, height 53-87 mm two variable end pieces |
| 04052536005604 | obelisc center piece, ø 20 mm, height 40-62 mm two variable end pieces |
| 04052536005598 | obelisc center piece, ø 20 mm, height 32-47 mm two variable end pieces |
| 04052536005581 | obelisc center piece, Ø 20 mm, height 25-37 mm one fix end piece, one variable end piece |
| 04052536005574 | obelisc center piece, ø 20 mm, height 20-28 mm one fix end piece, one variable end piece |
| 04052536005567 | obelisc locking screw |
| 04052536198818 | Shaft flexible for screwdriver, hex 3.5 mm |
| 04052536198795 | Locking rod flexible, length 450 mm |
| 04052536198788 | Expansion rod flexible, length 450 mm |
Trademark Results [obelisc]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OBELISC 79056766 3666923 Live/Registered |
Ulrich GmbH & Co. KG 2008-07-23 |
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