ENDOSKELETON® TCS 5086-1605
GUDID 00191375011736
Trial, 6 Deg Lordotic, Large, 5mm
TITAN SPINE, LLC
Spinal implant trial| Primary Device ID | 00191375011736 |
| NIH Device Record Key | 7883e530-a3df-4aa2-a8b4-64bb27ad755f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENDOSKELETON® TCS |
| Version Model Number | 5086-1605 |
| Catalog Number | 5086-1605 |
| 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 | 5 Millimeter |
| Height | 5 Millimeter |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
| Angle | 6 degree |
| Width | 18 Millimeter |
| Depth | 16 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191375011736 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142940
FDA Product Code
| HWT | TEMPLATE |
| OVE | Intervertebral fusion device with integrated fixation, cervical |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
[00191375011736]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-09-20 |
| Device Publish Date | 2016-12-15 |
On-Brand Devices [ENDOSKELETON® TCS]
| 00191375027331 | Fixed Angle Drill - Driver |
| 00191375027324 | Fixed Angle Driver, Ancillary Handle |
| 00191375025788 | 45 Deg, Curved, Retractable Awl |
| 00191375025771 | Bayonetted Awl Guide, 2.5mm |
| 00191375025764 | Bayonetted Awl Guide, 2.0mm |
| 00191375025757 | CURVED, FIXED AWL, 2mm |
| 00191375025740 | STRAIGHT, FIXED AWL, 2mm |
| 00191375011941 | Implant Tray System |
| 00191375011934 | Instrument Rigid Tray System |
| 00191375011927 | Bone Screw Extractor |
| 00191375011910 | Torque Limiting Handle |
| 00191375011903 | U-Joint, Drill |
| 00191375011897 | No 8 Hexalobe, U-Joint Driver |
| 00191375011880 | U-Joint, Awl |
| 00191375011873 | Inserter |
| 00191375011866 | Awl Guide |
| 00191375011859 | Swivel Driver, No 8 Hexalobe |
| 00191375011842 | No 8 Hexalobe, Straight Driver |
| 00191375011835 | Curved, Fixed Awl |
| 00191375011828 | Straight, Fixed Awl |
| 00191375011811 | Mallet |
| 00191375011804 | Ratcheting Handle |
| 00191375011798 | Retractable Straight Awl, Straight |
| 00191375011781 | Rongeur |
| 00191375011774 | Slap Hammer |
| 00191375011767 | Trial, 6 Deg Lordotic, Large, 11mm |
| 00191375011750 | Trial, 6 Deg Lordotic, Large, 9mm |
| 00191375011743 | Trial, 6 Deg Lordotic, Large, 7mm |
| 00191375011736 | Trial, 6 Deg Lordotic, Large, 5mm |
| 00191375011729 | Trial, 6 Deg Lordotic, Medium, 11mm |
| 00191375011712 | Trial, 6 Deg Lordotic, Medium, 9mm |
| 00191375011705 | Trial, 6 Deg Lordotic, Medium, 7mm |
| 00191375011699 | Trial, 6 Deg Lordotic, Medium, 5mm |
| 00191375011682 | Trial, 6 Deg Lordotic, Small, 11mm |
| 00191375011675 | Trial, 6 Deg Lordotic, Small, 9mm |
| 00191375011668 | Trial, 6 Deg Lordotic, Small, 7mm |
| 00191375011651 | Trial, 6 Deg Lordotic, Small, 5mm |
| 00191375011644 | Bone Screw, Locking, 3.8mm x 20mm |
| 00191375011637 | Bone Screw, Locking, 3.8mm x 19mm |
| 00191375011620 | Bone Screw, Locking, 3.8mm x 18mm |
| 00191375011613 | Bone Screw, Locking, 3.8mm x 17mm |
| 00191375011606 | Bone Screw, Locking, 3.8mm x 16mm |
| 00191375011590 | Bone Screw, Locking, 3.8mm x 15mm |
| 00191375011583 | Bone Screw, Locking, 3.8mm x 14mm |
| 00191375011576 | Bone Screw, Locking, 3.8mm x 13mm |
| 00191375011569 | Bone Screw, Locking, 3.5mm x 20mm |
| 00191375011552 | Bone Screw, Locking, 3.5mm x 19mm |
| 00191375011545 | Bone Screw, Locking, 3.5mm x 18mm |
| 00191375011538 | Bone Screw, Locking, 3.5mm x 17mm |
| 00191375011521 | Bone Screw, Locking, 3.5mm x 16mm |
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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