ENDOSKELETON® TA 2112-9112
GUDID 00191375002123
Trial, 12 Deg Lordotic, Standard, 12mm
TITAN SPINE, LLC
Spinal implant trial| Primary Device ID | 00191375002123 |
| NIH Device Record Key | c6edc340-929e-4cd2-a65a-4931a8c930bc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENDOSKELETON® TA |
| Version Model Number | 2112-9112 |
| Catalog Number | 2112-9112 |
| 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 | 12 Millimeter |
| Height | 12 Millimeter |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Width | 32 Millimeter |
| Depth | 21 Millimeter |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191375002123 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K080615
FDA Product Code
| HWT | TEMPLATE |
| MAX | Intervertebral fusion device with bone graft, lumbar |
| OVD | Intervertebral fusion device with integrated fixation, lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
[00191375002123]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-09-20 |
| Device Publish Date | 2016-12-15 |
On-Brand Devices [ENDOSKELETON® TA]
| 00191375002499 | Distractor, Hybrid, 36 x 21 x 17mm |
| 00191375002482 | Distractor, Hybrid, 36 x 21 x 15mm |
| 00191375002475 | Distractor, Hybrid, 36 x 21 x 13mm |
| 00191375002468 | Distractor, Hybrid, 36 x 21 x 11mm |
| 00191375002451 | Distractor, Hybrid, 36 x 21 x 9mm |
| 00191375002444 | Distractor, Hybrid, 36 x 21 x 8mm |
| 00191375002376 | Trial, 12 Deg Lordotic, X-Large, 17mm |
| 00191375002369 | Trial, 12 Deg Lordotic, X-Large, 16mm |
| 00191375002352 | Trial, 12 Deg Lordotic, X-Large, 15mm |
| 00191375002345 | Trial, 12 Deg Lordotic, X-Large, 14mm |
| 00191375002338 | Trial, 12 Deg Lordotic, X-Large, 13mm |
| 00191375002321 | Trial, 12 Deg Lordotic, X-Large, 12mm |
| 00191375002314 | Trial, 12 Deg Lordotic, X-Large, 11mm |
| 00191375002307 | Trial, 12 Deg Lordotic, X-Large, 10mm |
| 00191375002291 | Trial, 12 Deg Lordotic, X-Large, 9mm |
| 00191375002284 | Trial, 12 Deg Lordotic, X-Large, 8mm |
| 00191375002277 | Trial, 12 Deg Lordotic, Large, 17mm |
| 00191375002260 | Trial, 12 Deg Lordotic, Large, 16mm |
| 00191375002253 | Trial, 12 Deg Lordotic, Large, 15mm |
| 00191375002246 | Trial, 12 Deg Lordotic, Large, 14mm |
| 00191375002239 | Trial, 12 Deg Lordotic, Large, 13mm |
| 00191375002222 | Trial, 12 Deg Lordotic, Large, 12mm |
| 00191375002215 | Trial, 12 Deg Lordotic, Large, 11mm |
| 00191375002208 | Trial, 12 Deg Lordotic, Large, 10mm |
| 00191375002192 | Trial, 12 Deg Lordotic, Large, 9mm |
| 00191375002185 | Trial, 12 Deg Lordotic, Large, 8mm |
| 00191375002178 | Trial, 12 Deg Lordotic, Standard, 17mm |
| 00191375002161 | Trial, 12 Deg Lordotic, Standard, 16mm |
| 00191375002154 | Trial, 12 Deg Lordotic, Standard, 15mm |
| 00191375002147 | Trial, 12 Deg Lordotic, Standard, 14mm |
| 00191375002130 | Trial, 12 Deg Lordotic, Standard, 13mm |
| 00191375002123 | Trial, 12 Deg Lordotic, Standard, 12mm |
| 00191375002116 | Trial, 12 Deg Lordotic, Standard, 11mm |
| 00191375002109 | Trial, 12 Deg Lordotic, Standard, 10mm |
| 00191375002093 | Trial, 12 Deg Lordotic, Standard, 9mm |
| 00191375002086 | Trial, 12 Deg Lordotic, Standard, 8mm |
| 00191375001256 | Implant Case |
| 00191375001249 | Implant Tray with Caddies |
| 00191375001232 | Instrument Case |
| 00191375001225 | 12 Deg Lordotic, Rasp, X-Large, 16mm |
| 00191375001218 | 12 Deg Lordotic, Rasp, X-Large, 15mm |
| 00191375001201 | 12 Deg Lordotic, Rasp, X-Large, 14mm |
| 00191375001195 | 12 Deg Lordotic, Rasp, X-Large, 13mm |
| 00191375001188 | 12 Deg Lordotic, Rasp, X-Large, 12mm |
| 00191375001171 | 12 Deg Lordotic, Rasp, X-Large, 11mm |
| 00191375001164 | 12 Deg Lordotic, Rasp, X-Large, 10mm |
| 00191375001157 | 12 Deg Lordotic, Rasp, Large, 16mm |
| 00191375001140 | 12 Deg Lordotic, Rasp, Large, 15mm |
| 00191375001133 | 12 Deg Lordotic, Rasp, Large, 14mm |
| 00191375001126 | 12 Deg Lordotic, Rasp, Large, 13mm |
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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