ENDOSKELETON® TL 7107-0413
GUDID 00191375006626
Interbody Fusion Device 7 Degree 55 (M/L) 18 (A/P) 13 mm
TITAN SPINE, LLC
Metallic spinal fusion cage, non-sterile| Primary Device ID | 00191375006626 |
| NIH Device Record Key | a19c8829-3b1b-41ad-be4b-a2ba927f1c5a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENDOSKELETON® TL |
| Version Model Number | 7107-0413 |
| Catalog Number | 7107-0413 |
| 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 | true |
| 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
| Length | 55 Millimeter |
| Length | 55 Millimeter |
| Length | 55 Millimeter |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 13 Millimeter |
| Width | 18 Millimeter |
| Device Size Text, specify | 0 |
| Length | 55 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191375006626 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K140055
FDA Product Code
| MAX | Intervertebral fusion device with bone graft, lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
Moist Heat or Steam Sterilization
[00191375006626]
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® TL]
| 00191375027751 | Quick Inserter Attachment 18mm |
| 00191375027744 | Quick Inserter Attachment 22mm |
| 00191375010142 | Retractor System |
| 00191375010135 | Retractor, Disposable Light Mat |
| 00191375010128 | Retractor, Disposable Probe |
| 00191375009801 | Angled Surgical Case |
| 00191375009795 | Threaded Inserter Angled |
| 00191375009788 | Angled, Standard Inserter, 22mm |
| 00191375009771 | Angled, Standard Inserter, 18mm |
| 00191375009764 | Graft Tamp, Angled |
| 00191375009757 | Cup Curette, Angled, Large, Right |
| 00191375009740 | Cup Curette, Angled, Large, Left |
| 00191375009733 | Cup Curette, Angled, Small, Right |
| 00191375009726 | Cup Curette, Angled, Small, Left |
| 00191375009719 | Down Angled, Ring Curette |
| 00191375009702 | Up Angled, Ring Curette |
| 00191375009696 | Down Angled, Cobb Elevator |
| 00191375009689 | Up Angled, Cobb Elevator |
| 00191375009672 | 5mm Pituitary Rongeur, Angled, Left |
| 00191375009665 | 5mm Pituitary Rongeur, Angled, Right |
| 00191375009658 | 3mm Pituitary Rongeur, Angled, Left |
| 00191375009641 | 3mm Pituitary Rongeur, Angled, Right |
| 00191375009634 | Rigid Container System |
| 00191375009627 | Bipolar Forceps |
| 00191375009610 | Distractor Wedge, 6mm |
| 00191375009603 | Trial, 7 Deg Lordotic, 22mm x 14mm |
| 00191375009597 | Trial, 7 Deg Lordotic, 22mm x 13mm |
| 00191375009580 | Trial, 7 Deg Lordotic, 22mm x 12mm |
| 00191375009573 | Trial, 7 Deg Lordotic, 22mm x 11mm |
| 00191375009566 | Trial, 7 Deg Lordotic, 22mm x 10mm |
| 00191375009559 | Trial, 7 Deg Lordotic, 22mm x 9mm |
| 00191375009542 | Trial, 7 Deg Lordotic, 22mm x 8mm |
| 00191375009535 | Trial, 7 Deg Lordotic, 18mm x 14mm |
| 00191375009528 | Trial, 7 Deg Lordotic, 18mm x 13mm |
| 00191375009511 | Trial, 7 Deg Lordotic, 18mm x 12mm |
| 00191375009504 | Trial, 7 Deg Lordotic, 18mm x 11mm |
| 00191375009498 | Trial, 7 Deg Lordotic, 18mm x 10mm |
| 00191375009481 | Trial, 7 Deg Lordotic, 18mm x 9mm |
| 00191375009474 | Trial, 7 Deg Lordotic, 18mm x 8mm |
| 00191375009467 | Parallel, Rasp, 22 x 13mm |
| 00191375009450 | Parallel, Rasp, 22 x 11mm |
| 00191375009443 | Parallel, Rasp, 22 x 9mm |
| 00191375009436 | Parallel, Rasp, 22 x 7mm |
| 00191375009429 | Parallel, Rasp, 18 x 13mm |
| 00191375009412 | Parallel, Rasp, 18 x 11mm |
| 00191375009405 | Parallel, Rasp, 18 x 9mm |
| 00191375009399 | Parallel, Rasp, 18 x 7mm |
| 00191375009382 | Parallel, Rasp, 18 x 5mm |
| 00191375009375 | Slap Hammer |
| 00191375009368 | French No 12, Suction Tip |
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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