ENDOSKELETON® TC 5166-1409
GUDID 00191375003670
Interbody Fusion Device 6 Degree Medium 9mm
TITAN SPINE, LLC
Metallic spinal fusion cage, non-sterile| Primary Device ID | 00191375003670 |
| NIH Device Record Key | 23bb5b21-ca6d-423b-b626-5e0f19ac9359 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENDOSKELETON® TC |
| Version Model Number | 5166-1409 |
| Catalog Number | 5166-1409 |
| 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
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Height | 9 Millimeter |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191375003670 [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 | true |
| Device Is Sterile | false |
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
[00191375003670]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-12-15 |
On-Brand Devices [ENDOSKELETON® TC]
| 00191375004332 | Lordotic Implant Caddy |
| 00191375004325 | Surgical Case Paragon Rework Prints |
| 00191375004318 | Surgical Tray System |
| 00191375004301 | Instrument Tray |
| 00191375004295 | PARALLEL, TRIAL, LARGE, 12MM |
| 00191375004288 | PARALLEL, TRIAL, LARGE, 11MM |
| 00191375004271 | PARALLEL, TRIAL, LARGE, 10MM |
| 00191375004264 | PARALLEL, TRIAL, LARGE, 9MM |
| 00191375004257 | PARALLEL, TRIAL, LARGE, 8MM |
| 00191375004240 | PARALLEL, TRIAL, LARGE, 7MM |
| 00191375004233 | PARALLEL, TRIAL, LARGE, 6MM |
| 00191375004226 | PARALLEL, TRIAL, LARGE, 5MM |
| 00191375004219 | PARALLEL, TRIAL, MEDIUM, 12MM |
| 00191375004202 | PARALLEL, TRIAL, MEDIUM, 11MM |
| 00191375004196 | PARALLEL, TRIAL, MEDIUM, 10MM |
| 00191375004189 | PARALLEL, TRIAL, MEDIUM, 9MM |
| 00191375004172 | PARALLEL, TRIAL, MEDIUM, 8MM |
| 00191375004165 | PARALLEL, TRIAL, MEDIUM, 7MM |
| 00191375004158 | PARALLEL, TRIAL, MEDIUM, 6MM |
| 00191375004141 | PARALLEL, TRIAL, MEDIUM, 5MM |
| 00191375004134 | PARALLEL, TRIAL, SMALL, 12MM |
| 00191375004127 | PARALLEL, TRIAL, SMALL, 11MM |
| 00191375004110 | PARALLEL, TRIAL, SMALL, 10MM |
| 00191375004103 | PARALLEL, TRIAL, SMALL, 9MM |
| 00191375004097 | PARALLEL, TRIAL, SMALL, 8MM |
| 00191375004080 | PARALLEL, TRIAL, SMALL, 7MM |
| 00191375004073 | PARALLEL, TRIAL, SMALL, 6MM |
| 00191375004066 | PARALLEL, TRIAL, SMALL, 5MM |
| 00191375004059 | Trial, 6 Deg Lordotic, Medium, 12mm |
| 00191375004042 | Trial, 6 Deg Lordotic, Medium, 11mm |
| 00191375004035 | Trial, 6 Deg Lordotic, Medium, 10mm |
| 00191375004028 | Trial, 6 Deg Lordotic, Medium, 9mm |
| 00191375004011 | Trial, 6 Deg Lordotic, Medium, 8mm |
| 00191375004004 | Trial, 6 Deg Lordotic, Medium, 7mm |
| 00191375003991 | Trial, 6 Deg Lordotic, Medium, 6mm |
| 00191375003984 | Trial, 6 Deg Lordotic, Medium, 5mm |
| 00191375003977 | Trial, 6 Deg Lordotic, Small, 12mm |
| 00191375003960 | Trial, 6 Deg Lordotic, Small, 11mm |
| 00191375003953 | Trial, 6 Deg Lordotic, Small, 10mm |
| 00191375003946 | Trial, 6 Deg Lordotic, Small, 9mm |
| 00191375003939 | Trial, 6 Deg Lordotic, Small, 8mm |
| 00191375003922 | Trial, 6 Deg Lordotic, Small, 7mm |
| 00191375003915 | Trial, 6 Deg Lordotic, Small, 6mm |
| 00191375003908 | Trial, 6 Deg Lordotic, Small, 5mm |
| 00191375003892 | Trial, 6 Deg Lordotic, Large, 12mm |
| 00191375003885 | Trial, 6 Deg Lordotic, Large, 11mm |
| 00191375003878 | Trial, 6 Deg Lordotic, Large, 10mm |
| 00191375003861 | Trial, 6 Deg Lordotic, Large, 9mm |
| 00191375003854 | Trial, 6 Deg Lordotic, Large, 8mm |
| 00191375003847 | Trial, 6 Deg Lordotic, Large, 7mm |
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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