ENDOSKELETON® TO Sterile Barrier System 3110-3115-S
GUDID 00191375020325
Interbody Fusion Device 0 Degree Convex Oblique 15mm
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 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 | 00191375020325 |
| NIH Device Record Key | 8cedcea2-417c-44d0-b744-0c1cefa33f52 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENDOSKELETON® TO Sterile Barrier System |
| Version Model Number | 3110-3115-S |
| Catalog Number | 3110-3115-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 | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
| Device Size Text, specify | 0 |
| Depth | 11 Millimeter |
| Width | 31 Millimeter |
| Device Size Text, specify | 0 |
| Height | 15 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191375020325 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K102067
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 | 5 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2016-12-15 |
On-Brand Devices [ENDOSKELETON® TO Sterile Barrier System]
| 00191375020608 | Interbody Fusion Device 4 Degree Oblique 16mm |
| 00191375020592 | Interbody Fusion Device 4 Degree Oblique 15mm |
| 00191375020585 | Interbody Fusion Device 4 Degree Oblique 14mm |
| 00191375020578 | Interbody Fusion Device 4 Degree Oblique 13mm |
| 00191375020561 | Interbody Fusion Device 4 Degree Oblique 12mm |
| 00191375020554 | Interbody Fusion Device 4 Degree Oblique 11mm |
| 00191375020547 | Interbody Fusion Device 4 Degree Oblique 10mm |
| 00191375020530 | Interbody Fusion Device 4 Degree Oblique 9mm |
| 00191375020523 | Interbody Fusion Device 4 Degree Oblique 8mm |
| 00191375020516 | Interbody Fusion Device 4 Degree PLIF 16mm |
| 00191375020509 | Interbody Fusion Device 4 Degree PLIF 15mm |
| 00191375020493 | Interbody Fusion Device 4 Degree PLIF 14mm |
| 00191375020486 | Interbody Fusion Device 4 Degree PLIF 13mm |
| 00191375020479 | Interbody Fusion Device 4 Degree PLIF 12mm |
| 00191375020462 | Interbody Fusion Device 4 Degree PLIF 11mm |
| 00191375020455 | Interbody Fusion Device 4 Degree PLIF 10mm |
| 00191375020448 | Interbody Fusion Device 4 Degree PLIF 9mm |
| 00191375020431 | Interbody Fusion Device 4 Degree PLIF 8mm |
| 00191375020424 | Interbody Fusion Device 4 Degree PLIF 16mm |
| 00191375020417 | Interbody Fusion Device 4 Degree PLIF 15mm |
| 00191375020400 | Interbody Fusion Device 4 Degree PLIF 14mm |
| 00191375020394 | Interbody Fusion Device 4 Degree PLIF 13mm |
| 00191375020387 | Interbody Fusion Device 4 Degree PLIF 12mm |
| 00191375020370 | Interbody Fusion Device 4 Degree PLIF 11mm |
| 00191375020363 | Interbody Fusion Device 4 Degree PLIF 10mm |
| 00191375020356 | Interbody Fusion Device 4 Degree PLIF 9mm |
| 00191375020349 | Interbody Fusion Device 4 Degree PLIF 8mm |
| 00191375020332 | Interbody Fusion Device 0 Degree Convex Oblique 16mm |
| 00191375020325 | Interbody Fusion Device 0 Degree Convex Oblique 15mm |
| 00191375020318 | Interbody Fusion Device 0 Degree Convex Oblique 14mm |
| 00191375020301 | Interbody Fusion Device 0 Degree Convex Oblique 13mm |
| 00191375020295 | Interbody Fusion Device 0 Degree Convex Oblique 12mm |
| 00191375020288 | Interbody Fusion Device 0 Degree Convex Oblique 11mm |
| 00191375020271 | Interbody Fusion Device 0 Degree Convex Oblique 10mm |
| 00191375020264 | Interbody Fusion Device 0 Degree Convex Oblique 9mm |
| 00191375020257 | Interbody Fusion Device 0 Degree Convex Oblique 8mm |
| 00191375020240 | Interbody Fusion Device 0 Degree Convex PLIF 16mm |
| 00191375020233 | Interbody Fusion Device 0 Degree Convex PLIF 15mm |
| 00191375020226 | Interbody Fusion Device 0 Degree Convex PLIF 14mm |
| 00191375020219 | Interbody Fusion Device 0 Degree Convex PLIF 13mm |
| 00191375020202 | Interbody Fusion Device 0 Degree Convex PLIF 12mm |
| 00191375020196 | Interbody Fusion Device 0 Degree Convex PLIF 11mm |
| 00191375020189 | Interbody Fusion Device 0 Degree Convex PLIF 10mm |
| 00191375020172 | Interbody Fusion Device 0 Degree Convex PLIF 9mm |
| 00191375020165 | Interbody Fusion Device 0 Degree Convex PLIF 8mm |
| 00191375020158 | Interbody Fusion Device 0 Degree Convex PLIF 16mm |
| 00191375020141 | Interbody Fusion Device 0 Degree Convex PLIF 15mm |
| 00191375020134 | Interbody Fusion Device 0 Degree Convex PLIF 14mm |
| 00191375020127 | Interbody Fusion Device 0 Degree Convex PLIF 13mm |
| 00191375020110 | Interbody Fusion Device 0 Degree Convex PLIF 12mm |
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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