ENDOSKELETON® TA Sterile Barrier System 2107-0312-S
GUDID 00191375019084
Interbody Fusion Device 7 Degree X-Large 12mm
TITAN SPINE, LLC
Metallic spinal interbody fusion cage| Primary Device ID | 00191375019084 |
| NIH Device Record Key | 0e5c01d6-83c4-4471-baf8-3f4511f715fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENDOSKELETON® TA Sterile Barrier System |
| Version Model Number | 2107-0312-S |
| Catalog Number | 2107-0312-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 | 12 Millimeter |
| Height | 12 Millimeter |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
| Depth | 27 Millimeter |
| Width | 40 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Device Size Text, specify | 0 |
| Height | 12 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191375019084 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K080615
FDA Product Code
| MAX | Intervertebral fusion device with bone graft, lumbar |
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® TA Sterile Barrier System]
| 00191375019138 | Interbody Fusion Device 7 Degree X-Large 17mm |
| 00191375019121 | Interbody Fusion Device 7 Degree X-Large 16mm |
| 00191375019114 | Interbody Fusion Device 7 Degree X-Large 15mm |
| 00191375019107 | Interbody Fusion Device 7 Degree X-Large 14mm |
| 00191375019091 | Interbody Fusion Device 7 Degree X-Large 13mm |
| 00191375019084 | Interbody Fusion Device 7 Degree X-Large 12mm |
| 00191375019077 | Interbody Fusion Device 7 Degree X-Large 11mm |
| 00191375019060 | Interbody Fusion Device 7 Degree X-Large 10mm |
| 00191375019053 | Interbody Fusion Device 7 Degree Large 17mm |
| 00191375019046 | Interbody Fusion Device 7 Degree Large 16mm |
| 00191375019039 | Interbody Fusion Device 7 Degree Large 15mm |
| 00191375019022 | Interbody Fusion Device 7 Degree Large 14mm |
| 00191375019015 | Interbody Fusion Device 7 Degree Large 13mm |
| 00191375019008 | Interbody Fusion Device 7 Degree Large 12mm |
| 00191375018995 | Interbody Fusion Device 7 Degree Large 11mm |
| 00191375018988 | Interbody Fusion Device 7 Degree Large 10mm |
| 00191375018971 | Interbody Fusion Device 7 Degree Standard 17mm |
| 00191375018964 | Interbody Fusion Device 7 Degree Standard 16mm |
| 00191375018957 | Interbody Fusion Device 7 Degree Standard 15mm |
| 00191375018940 | Interbody Fusion Device 7 Degree Standard 14mm |
| 00191375018933 | Interbody Fusion Device 7 Degree Standard 13mm |
| 00191375018926 | Interbody Fusion Device 7 Degree Standard 12mm |
| 00191375018919 | Interbody Fusion Device 7 Degree Standard 11mm |
| 00191375018902 | Interbody Fusion Device 7 Degree Standard 10mm |
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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