ENDOSKELETON® TAS nanoLOCK® Surface Technology 2312-1112-N
GUDID 00191375014010
Interbody Fusion Device 12 Degree Hybrid 12mm
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 | 00191375014010 |
| NIH Device Record Key | add50890-3a44-408e-88ae-b161b7cb2df1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENDOSKELETON® TAS nanoLOCK® Surface Technology |
| Version Model Number | 2312-1112-N |
| Catalog Number | 2312-1112-N |
| 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 |
| Angle | 12 degree |
| Device Size Text, specify | 0 |
| Depth | 21 Millimeter |
| Width | 36 Millimeter |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Device Size Text, specify | 0 |
| Depth | 21 Millimeter |
| Width | 36 Millimeter |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Device Size Text, specify | 0 |
| Depth | 21 Millimeter |
| Width | 36 Millimeter |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Device Size Text, specify | 0 |
| Depth | 21 Millimeter |
| Width | 36 Millimeter |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Device Size Text, specify | 0 |
| Depth | 21 Millimeter |
| Width | 36 Millimeter |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Device Size Text, specify | 0 |
| Depth | 21 Millimeter |
| Width | 36 Millimeter |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Device Size Text, specify | 0 |
| Depth | 21 Millimeter |
| Width | 36 Millimeter |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Device Size Text, specify | 0 |
| Depth | 21 Millimeter |
| Width | 36 Millimeter |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Device Size Text, specify | 0 |
| Depth | 21 Millimeter |
| Width | 36 Millimeter |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Device Size Text, specify | 0 |
| Depth | 21 Millimeter |
| Width | 36 Millimeter |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Device Size Text, specify | 0 |
| Depth | 21 Millimeter |
| Width | 36 Millimeter |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Device Size Text, specify | 0 |
| Depth | 21 Millimeter |
| Width | 36 Millimeter |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 12 degree |
| Device Size Text, specify | 0 |
| Depth | 21 Millimeter |
| Width | 36 Millimeter |
| Height | 12 Millimeter |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191375014010 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K111626
FDA Product Code
| OVD | Intervertebral fusion device with integrated fixation, 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® TAS nanoLOCK® Surface Technology]
| 00191375014300 | Interbody Fusion Device 12 Degree X-Large 17mm |
| 00191375014294 | Interbody Fusion Device 12 Degree X-Large 16mm |
| 00191375014287 | Interbody Fusion Device 12 Degree X-Large 15mm |
| 00191375014270 | Interbody Fusion Device 12 Degree X-Large 14mm |
| 00191375014263 | Interbody Fusion Device 12 Degree X-Large 13mm |
| 00191375014256 | Interbody Fusion Device 12 Degree X-Large 12mm |
| 00191375014249 | Interbody Fusion Device 12 Degree X-Large 11mm |
| 00191375014232 | Interbody Fusion Device 12 Degree X-Large 10mm |
| 00191375014225 | Interbody Fusion Device 12 Degree Large 17mm |
| 00191375014218 | Interbody Fusion Device 12 Degree Large 16mm |
| 00191375014201 | Interbody Fusion Device 12 Degree Large 15mm |
| 00191375014195 | Interbody Fusion Device 12 Degree Large 14mm |
| 00191375014188 | Interbody Fusion Device 12 Degree Large 13mm |
| 00191375014171 | Interbody Fusion Device 12 Degree Large 12mm |
| 00191375014164 | Interbody Fusion Device 12 Degree Large 11mm |
| 00191375014157 | Interbody Fusion Device 12 Degree Large 10mm |
| 00191375014140 | Interbody Fusion Device 12 Degree Standard 17mm |
| 00191375014133 | Interbody Fusion Device 12 Degree Standard 16mm |
| 00191375014126 | Interbody Fusion Device 12 Degree Standard 15mm |
| 00191375014119 | Interbody Fusion Device 12 Degree Standard 14mm |
| 00191375014102 | Interbody Fusion Device 12 Degree Standard 13mm |
| 00191375014096 | Interbody Fusion Device 12 Degree Standard 12mm |
| 00191375014089 | Interbody Fusion Device 12 Degree Standard 11mm |
| 00191375014072 | Interbody Fusion Device 12 Degree Standard 10mm |
| 00191375014065 | Interbody Fusion Device 12 Degree Hybrid 17mm |
| 00191375014058 | Interbody Fusion Device 12 Degree Hybrid 16mm |
| 00191375014041 | Interbody Fusion Device 12 Degree Hybrid 15mm |
| 00191375014034 | Interbody Fusion Device 12 Degree Hybrid 14mm |
| 00191375014027 | Interbody Fusion Device 12 Degree Hybrid 13mm |
| 00191375014010 | Interbody Fusion Device 12 Degree Hybrid 12mm |
| 00191375014003 | Interbody Fusion Device 12 Degree Hybrid 11mm |
| 00191375013990 | Interbody Fusion Device 12 Degree Hybrid 10mm |
| 00191375013983 | Interbody Fusion Device 7 Degree X-Large 17mm |
| 00191375013976 | Interbody Fusion Device 7 Degree X-Large 16mm |
| 00191375013969 | Interbody Fusion Device 7 Degree X-Large 15mm |
| 00191375013952 | Interbody Fusion Device 7 Degree X-Large 14mm |
| 00191375013945 | Interbody Fusion Device 7 Degree X-Large 13mm |
| 00191375013938 | Interbody Fusion Device 7 Degree X-Large 12mm |
| 00191375013921 | Interbody Fusion Device 7 Degree X-Large 11mm |
| 00191375013914 | Interbody Fusion Device 7 Degree X-Large 10mm |
| 00191375013907 | Interbody Fusion Device 7 Degree Large 17mm |
| 00191375013891 | Interbody Fusion Device 7 Degree Large 16mm |
| 00191375013884 | Interbody Fusion Device 7 Degree Large 15mm |
| 00191375013877 | Interbody Fusion Device 7 Degree Large 14mm |
| 00191375013860 | Interbody Fusion Device 7 Degree Large 13mm |
| 00191375013853 | Interbody Fusion Device 7 Degree Large 12mm |
| 00191375013846 | Interbody Fusion Device 7 Degree Large 11mm |
| 00191375013839 | Interbody Fusion Device 7 Degree Large 10mm |
| 00191375013822 | Interbody Fusion Device 7 Degree Standard 17mm |
| 00191375013815 | Interbody Fusion Device 7 Degree Standard 16mm |
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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