ENDOSKELETON® TO 3210-3108
GUDID 00191375030188
Trial, Oblique, 8mm
TITAN SPINE, LLC
Spinal implant trial| Primary Device ID | 00191375030188 |
| NIH Device Record Key | de7f38b9-2911-4092-873f-9015079f3a0c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENDOSKELETON® TO |
| Version Model Number | 3210-3108 |
| Catalog Number | 3210-3108 |
| 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
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
| Height | 8 Millimeter |
| Depth | 11 Millimeter |
| Device Size Text, specify | 0 |
| Width | 31 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191375030188 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K102067
FDA Product Code
| HWT | TEMPLATE |
| MAX | Intervertebral fusion device with bone graft, lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
[00191375030188]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-08 |
| Device Publish Date | 2019-09-30 |
On-Brand Devices [ENDOSKELETON® TO]
| 00191375004981 | Odd Size Trays |
| 00191375004974 | Perforated Tray System |
| 00191375004967 | Trial, PLIF, 15mm |
| 00191375004950 | Trial, PLIF, 14mm |
| 00191375004943 | Trial, PLIF, 13mm |
| 00191375004936 | Trial, PLIF, 12mm |
| 00191375004929 | Trial, PLIF, 11mm |
| 00191375004912 | Trial, PLIF, 10mm |
| 00191375004905 | Trial, PLIF, 9mm |
| 00191375004899 | Trial, PLIF, 8mm |
| 00191375004882 | Remover Implant, Threaded |
| 00191375004875 | Interbody Fusion Device 4 Degree Oblique 16mm |
| 00191375004868 | Interbody Fusion Device 4 Degree Oblique 15mm |
| 00191375004851 | Interbody Fusion Device 4 Degree Oblique 14mm |
| 00191375004844 | Interbody Fusion Device 4 Degree Oblique 13mm |
| 00191375004837 | Interbody Fusion Device 4 Degree Oblique 12mm |
| 00191375004820 | Interbody Fusion Device 4 Degree Oblique 11mm |
| 00191375004813 | Interbody Fusion Device 4 Degree Oblique 10mm |
| 00191375004806 | Interbody Fusion Device 4 Degree Oblique 9mm |
| 00191375004790 | Interbody Fusion Device 4 Degree Oblique 8mm |
| 00191375004783 | Interbody Fusion Device 4 Degree PLIF 16mm |
| 00191375004776 | Interbody Fusion Device 4 Degree PLIF 15mm |
| 00191375004769 | Interbody Fusion Device 4 Degree PLIF 14mm |
| 00191375004752 | Interbody Fusion Device 4 Degree PLIF 13mm |
| 00191375004745 | Interbody Fusion Device 4 Degree PLIF 12mm |
| 00191375004738 | Interbody Fusion Device 4 Degree PLIF 11mm |
| 00191375004721 | Interbody Fusion Device 4 Degree PLIF 10mm |
| 00191375004714 | Interbody Fusion Device 4 Degree PLIF 9mm |
| 00191375004707 | Interbody Fusion Device 4 Degree PLIF 8mm |
| 00191375004691 | Interbody Fusion Device 4 Degree PLIF 16mm |
| 00191375004684 | Interbody Fusion Device 4 Degree PLIF 15mm |
| 00191375004677 | Interbody Fusion Device 4 Degree PLIF 14mm |
| 00191375004660 | Interbody Fusion Device 4 Degree PLIF 13mm |
| 00191375004653 | Interbody Fusion Device 4 Degree PLIF 12mm |
| 00191375004646 | Interbody Fusion Device 4 Degree PLIF 11mm |
| 00191375004639 | Interbody Fusion Device 4 Degree PLIF 10mm |
| 00191375004622 | Interbody Fusion Device 4 Degree PLIF 9mm |
| 00191375004615 | Interbody Fusion Device 4 Degree PLIF 8mm |
| 00191375004608 | Interbody Fusion Device 0 Degree Convex Oblique 16mm |
| 00191375004592 | Interbody Fusion Device 0 Degree Convex Oblique 15mm |
| 00191375004585 | Interbody Fusion Device 0 Degree Convex Oblique 14mm |
| 00191375004578 | Interbody Fusion Device 0 Degree Convex Oblique 13mm |
| 00191375004561 | Interbody Fusion Device 0 Degree Convex Oblique 12mm |
| 00191375004554 | Interbody Fusion Device 0 Degree Convex Oblique 11mm |
| 00191375004547 | Interbody Fusion Device 0 Degree Convex Oblique 10mm |
| 00191375004530 | Interbody Fusion Device 0 Degree Convex Oblique 9mm |
| 00191375004523 | Interbody Fusion Device 0 Degree Convex Oblique 8mm |
| 00191375004516 | Interbody Fusion Device 0 Degree Convex PLIF 16mm |
| 00191375004509 | Interbody Fusion Device 0 Degree Convex PLIF 15mm |
| 00191375004493 | Interbody Fusion Device 0 Degree Convex PLIF 14mm |
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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