ENDOSKELETON® TA Sterile Barrier System 2107-0317-S
GUDID 00191375019138
Interbody Fusion Device 7 Degree X-Large 17mm
TITAN SPINE, LLC
Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage| Primary Device ID | 00191375019138 |
| NIH Device Record Key | f4833926-b55d-41d9-b7ea-199aa9a2d0e4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENDOSKELETON® TA Sterile Barrier System |
| Version Model Number | 2107-0317-S |
| Catalog Number | 2107-0317-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
| Phone | +1(262)242-7801 |
| productinfo@titanspine.com | |
| Phone | +1(262)242-7801 |
| productinfo@titanspine.com | |
| Phone | +1(262)242-7801 |
| productinfo@titanspine.com | |
| Phone | +1(262)242-7801 |
| productinfo@titanspine.com | |
| Phone | +1(262)242-7801 |
| productinfo@titanspine.com | |
| Phone | +1(262)242-7801 |
| productinfo@titanspine.com | |
| Phone | +1(262)242-7801 |
| productinfo@titanspine.com | |
| Phone | +1(262)242-7801 |
| productinfo@titanspine.com | |
| Phone | +1(262)242-7801 |
| productinfo@titanspine.com | |
| Phone | +1(262)242-7801 |
| productinfo@titanspine.com | |
| Phone | +1(262)242-7801 |
| productinfo@titanspine.com | |
| Phone | +1(262)242-7801 |
| productinfo@titanspine.com | |
| Phone | +1(262)242-7801 |
| productinfo@titanspine.com | |
| Phone | +1(262)242-7801 |
| productinfo@titanspine.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Height | 17 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Height | 17 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Height | 17 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Height | 17 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Height | 17 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Height | 17 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Height | 17 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Height | 17 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Height | 17 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Height | 17 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Height | 17 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Height | 17 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Width | 40 Millimeter |
| Angle | 7 degree |
| Depth | 27 Millimeter |
| Height | 17 Millimeter |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191375019138 [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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.