Siconus™ SI Joint Fixation System
GUDID B030SCL110400
Ø11mm Bone Screw, Cannulated, 40mm
CAMBER SPINE TECHNOLOGIES, LLC
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile| Primary Device ID | B030SCL110400 |
| NIH Device Record Key | ac3306e3-e5f5-4b7a-9262-37c4d9700e15 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Siconus™ SI Joint Fixation System |
| Version Model Number | SCL-11-040 |
| Company DUNS | 054205979 |
| Company Name | CAMBER SPINE TECHNOLOGIES, LLC |
| Device Count | 1 |
| DM Exempt | false |
| 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
| Phone | 1-866-643-0739 |
| customerservice@cambermedtech.com | |
| Phone | 1-866-643-0739 |
| customerservice@cambermedtech.com |
Device Dimensions
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
| Length | 40 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B030SCL110400 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162121
FDA Product Code
| OUR | Sacroiliac Joint Fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B030SCL110400]
Moist Heat or Steam Sterilization
[B030SCL110400]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-05 |
| Device Publish Date | 2017-02-07 |
On-Brand Devices [Siconus™ SI Joint Fixation System]
| B030SCL110650 | Ø11mm Bone Screw, Cannulated, 65mm |
| B030SCL110600 | Ø11mm Bone Screw, Cannulated, 60mm |
| B030SCL110550 | Ø11mm Bone Screw, Cannulated, 55mm |
| B030SCL110500 | Ø11mm Bone Screw, Cannulated, 50mm |
| B030SCL110450 | Ø11mm Bone Screw, Cannulated, 45mm |
| B030SCL110400 | Ø11mm Bone Screw, Cannulated, 40mm |
| B030SCL110350 | Ø11mm Bone Screw, Cannulated, 35mm |
| B030SCL070700 | Ø7mm Bone Screw, Cannulated, 70mm |
| B030SCL070650 | Ø7mm Bone Screw, Cannulated, 65mm |
| B030SCL070600 | Ø7mm Bone Screw, Cannulated, 60mm |
| B030SCL070550 | Ø7mm Bone Screw, Cannulated, 55mm |
| B030SCL070500 | Ø7mm Bone Screw, Cannulated, 50mm |
| B030SCL070450 | Ø7mm Bone Screw, Cannulated, 45mm |
| B030SCL070400 | Ø7mm Bone Screw, Cannulated, 40mm |
| B030SCL070350 | Ø7mm Bone Screw, Cannulated, 35mm |
| B030SCL070300 | Ø7mm Bone Screw, Cannulated, 30mm |
Trademark Results [Siconus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SICONUS 90614986 not registered Live/Pending |
Camber Spine Technologies, LLC 2021-03-31 |
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