ENDOSKELETON® TAS 2312-9209
GUDID 00191375028789
Trial, Anterolateral, 12 Deg Lordotic, Large, 9mm
TITAN SPINE, LLC
Spinal implant trial| Primary Device ID | 00191375028789 |
| NIH Device Record Key | 1d083dd9-8cc1-497c-a681-926947c518ee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENDOSKELETON® TAS |
| Version Model Number | 2312-9209 |
| Catalog Number | 2312-9209 |
| 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
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 24 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Height | 9 Millimeter |
| Width | 36 Millimeter |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191375028789 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K111626
FDA Product Code
| HWT | TEMPLATE |
| OVD | Intervertebral fusion device with integrated fixation, lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
Moist Heat or Steam Sterilization
[00191375028789]
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® TAS]
| 00191375028253 | Hyperlordotic Instrument Tray Sys, 16, 20° |
| 00191375028246 | Hyperlordotic Instrument Tray System, 16, 20, 24° |
| 00191375028239 | Hyperlordotic, One-Up, Anterolateral Inserter |
| 00191375028222 | Hyperlordotic, Two-Up, Anterolateral Inserter |
| 00191375028215 | 24 Deg Lordotic, Rasp, X-Large, 20mm |
| 00191375028208 | 24 Deg Lordotic, Rasp, X-Large, 18mm |
| 00191375028192 | 24 Deg Lordotic, Rasp, X-Large, 16mm |
| 00191375028185 | 24 Deg Lordotic, Rasp, X-Large, 14mm |
| 00191375028178 | 24 Deg Lordotic, Rasp, Large, 20mm |
| 00191375028161 | 24 Deg Lordotic, Rasp, Large, 18mm |
| 00191375028154 | 24 Deg Lordotic, Rasp, Large, 16mm |
| 00191375028147 | 24 Deg Lordotic, Rasp, Large, 14mm |
| 00191375028130 | 24 Deg Lordotic, Rasp, Standard, 20mm |
| 00191375028123 | 24 Deg Lordotic, Rasp, Standard, 18mm |
| 00191375028116 | 24 Deg Lordotic, Rasp, Standard, 16mm |
| 00191375028109 | 24 Deg Lordotic, Rasp, Standard, 14mm |
| 00191375028093 | 20 Deg Lordotic, Rasp, X-Large, 20mm |
| 00191375028086 | 20 Deg Lordotic, Rasp, X-Large, 18mm |
| 00191375028079 | 20 Deg Lordotic, Rasp, X-Large, 16mm |
| 00191375028062 | 20 Deg Lordotic, Rasp, X-Large, 14mm |
| 00191375028055 | 20 Deg Lordotic, Rasp, X-Large, 12mm |
| 00191375028048 | 20 Deg Lordotic, Rasp, Large, 20mm |
| 00191375028031 | 20 Deg Lordotic, Rasp, Large, 18mm |
| 00191375028024 | 20 Deg Lordotic, Rasp, Large, 16mm |
| 00191375028017 | 20 Deg Lordotic, Rasp, Large, 14mm |
| 00191375028000 | 20 Deg Lordotic, Rasp, Large, 12mm |
| 00191375027997 | 20 Deg Lordotic, Rasp, Standard, 20mm |
| 00191375027980 | 20 Deg Lordotic, Rasp, Standard, 18mm |
| 00191375027973 | 20 Deg Lordotic, Rasp, Standard, 16mm |
| 00191375027966 | 20 Deg Lordotic, Rasp, Standard, 14mm |
| 00191375027959 | 20 Deg Lordotic, Rasp, Standard, 12mm |
| 00191375027942 | 16 Deg Lordotic, Rasp, X-Large, 20mm |
| 00191375027935 | 16 Deg Lordotic, Rasp, X-Large, 18mm |
| 00191375027928 | 16 Deg Lordotic, Rasp, X-Large, 16mm |
| 00191375027911 | 16 Deg Lordotic, Rasp, X-Large, 14mm |
| 00191375027904 | 16 Deg Lordotic, Rasp, X-Large, 12mm |
| 00191375027898 | 16 Deg Lordotic, Rasp, X-Large, 10mm |
| 00191375027881 | 16 Deg Lordotic, Rasp, Large, 20mm |
| 00191375027874 | 16 Deg Lordotic, Rasp, Large, 18mm |
| 00191375027867 | 16 Deg Lordotic, Rasp, Large, 16mm |
| 00191375027850 | 16 Deg Lordotic, Rasp, Large, 14mm |
| 00191375027843 | 16 Deg Lordotic, Rasp, Large, 12mm |
| 00191375027836 | 16 Deg Lordotic, Rasp, Large, 10mm |
| 00191375027829 | 16 Deg Lordotic, Rasp, Standard, 20mm |
| 00191375027812 | 16 Deg Lordotic, Rasp, Standard, 18mm |
| 00191375027805 | 16 Deg Lordotic, Rasp, Standard, 16mm |
| 00191375027799 | 16 Deg Lordotic, Rasp, Standard, 14mm |
| 00191375027782 | 16 Deg Lordotic, Rasp, Standard, 12mm |
| 00191375027775 | 16 Deg Lordotic, Rasp, Standard, 10mm |
| 00191375027737 | Interbody Fusion Device 6.5mm Implant Bone Screw 35mm |
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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