ENDOSKELETON® TA VBR 2156-9318
GUDID 00191375035992
Trial, 7 Deg Lordotic, X-Large, 18mm
TITAN SPINE, LLC
Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial| Primary Device ID | 00191375035992 |
| NIH Device Record Key | 1d3c7882-513f-4a24-bc1f-fa0338352ec4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENDOSKELETON® TA VBR |
| Version Model Number | 2156-9318 |
| Catalog Number | 2156-9318 |
| Company DUNS | 623316978 |
| Company Name | TITAN SPINE, LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| 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 Dimensions
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Width | 40 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191375035992 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K032812
FDA Product Code
| MQP | Spinal vertebral body replacement device |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
[00191375035992]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-08 |
| Device Publish Date | 2019-09-30 |
On-Brand Devices [ENDOSKELETON® TA VBR]
| 00191375000143 | Implant Caddy |
| 00191375000136 | Trial, 7 Deg Lordotic, Large, 20mm |
| 00191375000129 | Trial, 7 Deg Lordotic, Large, 18mm |
| 00191375000112 | Trial, 7 Deg Lordotic, Standard, 20mm |
| 00191375000105 | Trial, 7 Deg Lordotic, Standard, 18mm |
| 00191375000099 | 7 Deg Lordotic, Rasp, Large, 20mm |
| 00191375000082 | 7 Deg Lordotic, Rasp, Large, 18mm |
| 00191375000075 | 7 Deg Lordotic, Rasp, Standard, 20mm |
| 00191375000068 | 7 Deg Lordotic, Rasp, Standard, 18mm |
| 00191375000051 | Interbody Fusion Device 7 Degree X-Large 20mm |
| 00191375000044 | Interbody Fusion Device 7 Degree X-Large 18mm |
| 00191375000037 | Interbody Fusion Device 7 Degree Large 20mm |
| 00191375000020 | Interbody Fusion Device 7 Degree Large 18mm |
| 00191375000013 | Interbody Fusion Device 7 Degree Standard 20mm |
| 00191375000006 | Interbody Fusion Device 7 Degree Standard 18mm |
| 00191375036012 | Trial, 7 Deg Lordotic, X-Large, 20mm |
| 00191375036005 | Trial, 7 Deg Lordotic, X-Large, 19mm |
| 00191375035992 | Trial, 7 Deg Lordotic, X-Large, 18mm |
| 00191375035985 | Trial, 7 Deg Lordotic, X-Large, 17mm |
| 00191375035978 | Trial, 7 Deg Lordotic, Large, 19mm |
| 00191375035961 | Trial, 7 Deg Lordotic, Large, 17mm |
| 00191375035954 | Trial, 7 Deg Lordotic, Standard, 19mm |
| 00191375035947 | Trial, 7 Deg Lordotic, Standard, 17mm |
| 00191375030287 | Trial, 7 Deg Lordotic, X-Large, 16mm |
| 00191375030270 | Trial, 7 Deg Lordotic, Large, 16mm |
| 00191375030263 | Trial, 7 Deg Lordotic, Standard, 16mm |
| 00191375052418 | Impant Caddy, Lid |
| 00191375028956 | Impant Caddy, Base |
Trademark Results [ENDOSKELETON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOSKELETON 76550301 3174488 Live/Registered |
TITAN SPINE, INC. 2003-09-22 |
 ENDOSKELETON 74130100 not registered Dead/Abandoned |
CAROLCO PICTURES INC. 1991-01-14 |
 ENDOSKELETON 74130099 1719530 Live/Registered |
STUDIOCANAL, S.A. 1991-01-14 |
 ENDOSKELETON 74124953 not registered Dead/Abandoned |
CAROLCO PICTURES INC. 1990-12-20 |
 ENDOSKELETON 74124952 not registered Dead/Abandoned |
CAROLCO PICTURES INC. 1990-12-20 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.