SiCure Sacroiliac Joint Fusion System 900.11.50
GUDID B43690011500
Sacroiliac Joint Fusion Implant, 11mm DIA. x 50mm LGTH.
ALEVIO, LLC
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile| Primary Device ID | B43690011500 |
| NIH Device Record Key | 57913f58-6a10-4496-81e7-36fc9c2fc550 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SiCure Sacroiliac Joint Fusion System |
| Version Model Number | 900.11.50 |
| Catalog Number | 900.11.50 |
| Company DUNS | 080354484 |
| Company Name | ALEVIO, 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 | false |
| 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
| Phone | +1 (205) 783-5778 |
| customerservice@aleviospine.co | |
| Phone | +1 (205) 783-5778 |
| customerservice@aleviospine.co | |
| Phone | +1 (205) 783-5778 |
| customerservice@aleviospine.com | |
| Phone | +1 (205) 783-5778 |
| customerservice@aleviospine.com | |
| Phone | +1 (205) 783-5778 |
| customerservice@aleviospine.com | |
| Phone | +1 (205) 783-5778 |
| customerservice@aleviospine.com | |
| Phone | +1 (205) 783-5778 |
| customerservice@aleviospine.com | |
| Phone | +1 (205) 783-5778 |
| customerservice@aleviospine.com | |
| Phone | +1 (205) 783-5778 |
| customerservice@aleviospine.com | |
| Phone | +1 (205) 783-5778 |
| customerservice@aleviospine.com | |
| Phone | +1 (205) 783-5778 |
| customerservice@aleviospine.com | |
| Phone | +1 (205) 783-5778 |
| customerservice@aleviospine.com | |
| Phone | +1 (205) 783-5778 |
| customerservice@aleviospine.com |
Device Dimensions
| Length | 50 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 11 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 11 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B43690011500 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141106
FDA Product Code
| OUR | Sacroiliac Joint Fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B43690011500]
Moist Heat or Steam Sterilization
[B43690011500]
Moist Heat or Steam Sterilization
[B43690011500]
Moist Heat or Steam Sterilization
[B43690011500]
Moist Heat or Steam Sterilization
[B43690011500]
Moist Heat or Steam Sterilization
[B43690011500]
Moist Heat or Steam Sterilization
[B43690011500]
Moist Heat or Steam Sterilization
[B43690011500]
Moist Heat or Steam Sterilization
[B43690011500]
Moist Heat or Steam Sterilization
[B43690011500]
Moist Heat or Steam Sterilization
[B43690011500]
Moist Heat or Steam Sterilization
[B43690011500]
Moist Heat or Steam Sterilization
[B43690011500]
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 | 2016-09-24 |
On-Brand Devices [SiCure Sacroiliac Joint Fusion System]
| B43690011600 | Sacroiliac Joint Fusion Implant, 11mm DIA. x 60mm LGTH. |
| B43690011550 | Sacroiliac Joint Fusion Implant, 11mm DIA. x 55mm LGTH. |
| B43690011500 | Sacroiliac Joint Fusion Implant, 11mm DIA. x 50mm LGTH. |
| B43690011450 | Sacroiliac Joint Fusion Implant, 11mm DIA. x 45mm LGTH. |
| B43690011400 | Sacroiliac Joint Fusion Implant, 11mm DIA. x 40mm LGTH. |
| B43690011350 | Sacroiliac Joint Fusion Implant, 11mm DIA. x 35mm LGTH. |
| B436900110 | Load Distribution Cap, 11mm DIA. |
| B436900095600 | Sacroiliac Joint Fusion Implant, 9.5mm DIA. x 60mm LGTH. |
| B436900095550 | Sacroiliac Joint Fusion Implant, 9.5mm DIA. x 55mm LGTH. |
| B436900095500 | Sacroiliac Joint Fusion Implant, 9.5mm DIA. x 50mm LGTH. |
| B436900095450 | Sacroiliac Joint Fusion Implant, 9.5mm DIA. x 45mm LGTH. |
| B436900095400 | Sacroiliac Joint Fusion Implant, 9.5mm DIA. x 40mm LGTH. |
| B436900095350 | Sacroiliac Joint Fusion Implant, 9.5mm DIA. x 35mm LGTH. |
| B4369000950 | Load Distribution Cap, 9.5mm DIA. |
Trademark Results [SiCure Sacroiliac Joint Fusion System]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SICURE SACROILIAC JOINT FUSION SYSTEM 86750147 not registered Dead/Abandoned |
Alevio, LLC 2015-09-08 |
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