ENDOSKELETON® TA VBR 2156-7118
GUDID 00191375000068
7 Deg Lordotic, Rasp, Standard, 18mm
TITAN SPINE, LLC
Bone file/rasp, manual| Primary Device ID | 00191375000068 |
| NIH Device Record Key | 5ce3aa58-f51a-44de-8134-1874e1c8b260 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENDOSKELETON® TA VBR |
| Version Model Number | 2156-7118 |
| Catalog Number | 2156-7118 |
| 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
| Height | 18 Millimeter |
| Height | 18 Millimeter |
| Height | 18 Millimeter |
| Device Size Text, specify | 0 |
| Width | 32 Millimeter |
| Angle | 7 degree |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Device Size Text, specify | 0 |
| Width | 32 Millimeter |
| Angle | 7 degree |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Device Size Text, specify | 0 |
| Width | 32 Millimeter |
| Angle | 7 degree |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Device Size Text, specify | 0 |
| Width | 32 Millimeter |
| Angle | 7 degree |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Device Size Text, specify | 0 |
| Width | 32 Millimeter |
| Angle | 7 degree |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Device Size Text, specify | 0 |
| Width | 32 Millimeter |
| Angle | 7 degree |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Device Size Text, specify | 0 |
| Width | 32 Millimeter |
| Angle | 7 degree |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Device Size Text, specify | 0 |
| Width | 32 Millimeter |
| Angle | 7 degree |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Device Size Text, specify | 0 |
| Width | 32 Millimeter |
| Angle | 7 degree |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Device Size Text, specify | 0 |
| Width | 32 Millimeter |
| Angle | 7 degree |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Device Size Text, specify | 0 |
| Width | 32 Millimeter |
| Angle | 7 degree |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Device Size Text, specify | 0 |
| Width | 32 Millimeter |
| Angle | 7 degree |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Device Size Text, specify | 0 |
| Width | 32 Millimeter |
| Angle | 7 degree |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Device Size Text, specify | 0 |
| Width | 32 Millimeter |
| Angle | 7 degree |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Device Size Text, specify | 0 |
| Width | 32 Millimeter |
| Angle | 7 degree |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Device Size Text, specify | 0 |
| Width | 32 Millimeter |
| Angle | 7 degree |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Device Size Text, specify | 0 |
| Width | 32 Millimeter |
| Angle | 7 degree |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Device Size Text, specify | 0 |
| Width | 32 Millimeter |
| Angle | 7 degree |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Device Size Text, specify | 0 |
| Width | 32 Millimeter |
| Angle | 7 degree |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Device Size Text, specify | 0 |
| Width | 32 Millimeter |
| Angle | 7 degree |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
| Device Size Text, specify | 0 |
| Width | 32 Millimeter |
| Angle | 7 degree |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 18 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191375000068 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K032812
FDA Product Code
| HTR | RASP |
| MQP | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00191375000068]
Moist Heat or Steam Sterilization
[00191375000068]
Moist Heat or Steam Sterilization
[00191375000068]
Moist Heat or Steam Sterilization
[00191375000068]
Moist Heat or Steam Sterilization
[00191375000068]
Moist Heat or Steam Sterilization
[00191375000068]
Moist Heat or Steam Sterilization
[00191375000068]
Moist Heat or Steam Sterilization
[00191375000068]
Moist Heat or Steam Sterilization
[00191375000068]
Moist Heat or Steam Sterilization
[00191375000068]
Moist Heat or Steam Sterilization
[00191375000068]
Moist Heat or Steam Sterilization
[00191375000068]
Moist Heat or Steam Sterilization
[00191375000068]
Moist Heat or Steam Sterilization
[00191375000068]
Moist Heat or Steam Sterilization
[00191375000068]
Moist Heat or Steam Sterilization
[00191375000068]
Moist Heat or Steam Sterilization
[00191375000068]
Moist Heat or Steam Sterilization
[00191375000068]
Moist Heat or Steam Sterilization
[00191375000068]
Moist Heat or Steam Sterilization
[00191375000068]
Moist Heat or Steam Sterilization
[00191375000068]
Moist Heat or Steam Sterilization
[00191375000068]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-09-05 |
| Device Publish Date | 2016-12-15 |
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 |
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