ENDOSKELETON® TC Sterile Barrier System 5160-1409-S
GUDID 00191375019718
Interbody Fusion Device Parallel Medium 9mm
TITAN SPINE, LLC
Metallic spinal interbody fusion cage| Primary Device ID | 00191375019718 |
| NIH Device Record Key | 09dc0e56-a4a4-4279-ac8c-ac1bfd748262 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENDOSKELETON® TC Sterile Barrier System |
| Version Model Number | 5160-1409-S |
| Catalog Number | 5160-1409-S |
| 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 | true |
| 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 | 9 Millimeter |
| Height | 9 Millimeter |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Depth | 14 Millimeter |
| Device Size Text, specify | 0 |
| Width | 16 Millimeter |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191375019718 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K100889
FDA Product Code
| ODP | Intervertebral fusion device with bone graft, cervical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2016-12-15 |
On-Brand Devices [ENDOSKELETON® TC Sterile Barrier System]
| 00191375020066 | Interbody Fusion Device 6 Degree Large 12mm |
| 00191375020059 | Interbody Fusion Device 6 Degree Large 11mm |
| 00191375020042 | Interbody Fusion Device 6 Degree Large 10mm |
| 00191375020035 | Interbody Fusion Device 6 Degree Large 9mm |
| 00191375020028 | Interbody Fusion Device 6 Degree Large 8mm |
| 00191375020011 | Interbody Fusion Device 6 Degree Large 7mm |
| 00191375020004 | Interbody Fusion Device 6 Degree Large 6mm |
| 00191375019992 | Interbody Fusion Device 6 Degree Large 5mm |
| 00191375019985 | Interbody Fusion Device 6 Degree Medium 12mm |
| 00191375019978 | Interbody Fusion Device 6 Degree Medium 11mm |
| 00191375019961 | Interbody Fusion Device 6 Degree Medium 10mm |
| 00191375019954 | Interbody Fusion Device 6 Degree Medium 9mm |
| 00191375019947 | Interbody Fusion Device 6 Degree Medium 8mm |
| 00191375019930 | Interbody Fusion Device 6 Degree Medium 7mm |
| 00191375019923 | Interbody Fusion Device 6 Degree Medium 6mm |
| 00191375019916 | Interbody Fusion Device 6 Degree Medium 5mm |
| 00191375019909 | Interbody Fusion Device 6 Degree Small 12mm |
| 00191375019893 | Interbody Fusion Device 6 Degree Small 11mm |
| 00191375019886 | Interbody Fusion Device 6 Degree Small 10mm |
| 00191375019879 | Interbody Fusion Device 6 Degree Small 9mm |
| 00191375019862 | Interbody Fusion Device 6 Degree Small 8mm |
| 00191375019855 | Interbody Fusion Device 6 Degree Small 7mm |
| 00191375019848 | Interbody Fusion Device 6 Degree Small 6mm |
| 00191375019831 | Interbody Fusion Device 6 Degree Small 5mm |
| 00191375019824 | Interbody Fusion Device Parallel Large 12mm |
| 00191375019817 | Interbody Fusion Device Parallel Large 11mm |
| 00191375019800 | Interbody Fusion Device Parallel Large 10mm |
| 00191375019794 | Interbody Fusion Device Parallel Large 9mm |
| 00191375019787 | Interbody Fusion Device Parallel Large 8mm |
| 00191375019770 | Interbody Fusion Device Parallel Large 7mm |
| 00191375019763 | Interbody Fusion Device Parallel Large 6mm |
| 00191375019756 | Interbody Fusion Device Parallel Large 5mm |
| 00191375019749 | Interbody Fusion Device Parallel Medium 12mm |
| 00191375019732 | Interbody Fusion Device Parallel Medium 11mm |
| 00191375019725 | Interbody Fusion Device Parallel Medium 10mm |
| 00191375019718 | Interbody Fusion Device Parallel Medium 9mm |
| 00191375019701 | Interbody Fusion Device Parallel Medium 8mm |
| 00191375019695 | Interbody Fusion Device Parallel Medium 7mm |
| 00191375019688 | Interbody Fusion Device Parallel Medium 6mm |
| 00191375019671 | Interbody Fusion Device Parallel Medium 5mm |
| 00191375019664 | Interbody Fusion Device Parallel Small 12mm |
| 00191375019657 | Interbody Fusion Device Parallel Small 11mm |
| 00191375019640 | Interbody Fusion Device Parallel Small 10mm |
| 00191375019633 | Interbody Fusion Device Parallel Small 9mm |
| 00191375019626 | Interbody Fusion Device Parallel Small 8mm |
| 00191375019619 | Interbody Fusion Device Parallel Small 7mm |
| 00191375019602 | Interbody Fusion Device Parallel Small 6mm |
| 00191375019596 | Interbody Fusion Device Parallel Small 5mm |
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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