SacroFuse
GUDID 00190361023364
Ø8MM FUSION SCREW, GEN II, SACROFUSE, 70MM
SPINEFRONTIER, INC.
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile| Primary Device ID | 00190361023364 |
| NIH Device Record Key | 224dfd85-1ba3-4469-b565-8ee9d34cda39 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SacroFuse |
| Version Model Number | 01-42400-70 |
| Company DUNS | 002003243 |
| Company Name | SPINEFRONTIER, INC. |
| 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(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com | |
| Phone | +1(866)914-7717 |
| customerservice@spinefrontier.com |
Device Dimensions
| Length | 70 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 70 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 70 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190361023364 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K150017
FDA Product Code
| OUR | Sacroiliac joint fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190361023364]
Moist Heat or Steam Sterilization
[00190361023364]
Moist Heat or Steam Sterilization
[00190361023364]
Moist Heat or Steam Sterilization
[00190361023364]
Moist Heat or Steam Sterilization
[00190361023364]
Moist Heat or Steam Sterilization
[00190361023364]
Moist Heat or Steam Sterilization
[00190361023364]
Moist Heat or Steam Sterilization
[00190361023364]
Moist Heat or Steam Sterilization
[00190361023364]
Moist Heat or Steam Sterilization
[00190361023364]
Moist Heat or Steam Sterilization
[00190361023364]
Moist Heat or Steam Sterilization
[00190361023364]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-07-09 |
| Device Publish Date | 2018-06-08 |
On-Brand Devices [SacroFuse]
| 00190361036289 | SCREW, SOLID WALL, CANNULATED, Ø12MM X 70MM, SACROFUSE |
| 00190361036272 | SCREW, SOLID WALL, CANNULATED, Ø12MM X 65MM, SACROFUSE |
| 00190361036265 | SCREW, SOLID WALL, CANNULATED, Ø12MM X 60MM, SACROFUSE |
| 00190361036258 | SCREW, SOLID WALL, CANNULATED, Ø12MM X 55MM, SACROFUSE |
| 00190361036241 | SCREW, SOLID WALL, CANNULATED, Ø12MM X 50MM, SACROFUSE |
| 00190361036234 | SCREW, SOLID WALL, CANNULATED, Ø12MM X 45MM, SACROFUSE |
| 00190361036227 | SCREW, SOLID WALL, CANNULATED, Ø12MM X 40MM, SACROFUSE |
| 00190361036210 | SCREW, SOLID WALL, CANNULATED, Ø12MM X 35MM, SACROFUSE |
| 00190361036203 | SCREW, SOLID WALL, CANNULATED, Ø12MM X 30MM, SACROFUSE |
| 00190361036197 | SCREW, SOLID WALL, CANNULATED, Ø10MM X 70MM, SACROFUSE |
| 00190361036180 | SCREW, SOLID WALL, CANNULATED, Ø10MM X 65MM, SACROFUSE |
| 00190361036173 | SCREW, SOLID WALL, CANNULATED, Ø10MM X 60MM, SACROFUSE |
| 00190361036166 | SCREW, SOLID WALL, CANNULATED, Ø10MM X 55MM, SACROFUSE |
| 00190361036159 | SCREW, SOLID WALL, CANNULATED, Ø10MM X 50MM, SACROFUSE |
| 00190361036142 | SCREW, SOLID WALL, CANNULATED, Ø10MM X 45MM, SACROFUSE |
| 00190361036135 | SCREW, SOLID WALL, CANNULATED, Ø10MM X 40MM, SACROFUSE |
| 00190361036128 | SCREW, SOLID WALL, CANNULATED, Ø10MM X 35MM, SACROFUSE |
| 00190361036111 | SCREW, SOLID WALL, CANNULATED, Ø10MM X 30MM, SACROFUSE |
| 00190361036104 | SCREW, SOLID WALL, CANNULATED, Ø8MM X 70MM, SACROFUSE |
| 00190361036098 | SCREW, SOLID WALL, CANNULATED, Ø8MM X 65MM, SACROFUSE |
| 00190361036081 | SCREW, SOLID WALL, CANNULATED, Ø8MM X 60MM, SACROFUSE |
| 00190361036074 | SCREW, SOLID WALL, CANNULATED, Ø8MM X 55MM, SACROFUSE |
| 00190361036067 | SCREW, SOLID WALL, CANNULATED, Ø8MM X 50MM, SACROFUSE |
| 00190361036050 | SCREW, SOLID WALL, CANNULATED, Ø8MM X 45MM, SACROFUSE |
| 00190361036043 | SCREW, SOLID WALL, CANNULATED, Ø8MM X 40MM, SACROFUSE |
| 00190361036036 | SCREW, SOLID WALL, CANNULATED, Ø8MM X 35MM, SACROFUSE |
| 00190361036029 | SCREW, SOLID WALL, CANNULATED, Ø8MM X 30MM, SACROFUSE |
| 00190361036012 | FENESTRATED SCREW, CANNULATED, Ø10MM x 70MM, SACROFUSE |
| 00190361036005 | FENESTRATED SCREW, CANNULATED, Ø10MM x 65MM, SACROFUSE |
| 00190361035992 | FENESTRATED SCREW, CANNULATED, Ø10MM x 60MM, SACROFUSE |
| 00190361035985 | FENESTRATED SCREW, CANNULATED, Ø10MM x 55MM, SACROFUSE |
| 00190361035978 | FENESTRATED SCREW, CANNULATED, Ø10MM x 50MM, SACROFUSE |
| 00190361035961 | FENESTRATED SCREW, CANNULATED, Ø10MM x 45MM, SACROFUSE |
| 00190361035954 | FENESTRATED SCREW, CANNULATED, Ø10MM x 40MM, SACROFUSE |
| 00190361035947 | FENESTRATED SCREW, CANNULATED, Ø10MM x 35MM, SACROFUSE |
| 00190361035930 | FENESTRATED SCREW, CANNULATED, Ø10MM x 30MM, SACROFUSE |
| 00190361035923 | FENESTRATED SCREW, CANNULATED, Ø12MM x 70MM, SACROFUSE |
| 00190361035916 | FENESTRATED SCREW, CANNULATED, Ø12MM x 65MM, SACROFUSE |
| 00190361035909 | FENESTRATED SCREW, CANNULATED, Ø12MM x 60MM, SACROFUSE |
| 00190361035893 | FENESTRATED SCREW, CANNULATED, Ø12MM x 55MM, SACROFUSE |
| 00190361035886 | FENESTRATED SCREW, CANNULATED, Ø12MM x 45MM, SACROFUSE |
| 00190361035879 | FENESTRATED SCREW, CANNULATED, Ø12MM x 35MM, SACROFUSE |
| 00190361035862 | FENESTRATED SCREW, CANNULATED, Ø12MM x 50MM, SACROFUSE |
| 00190361035855 | FENESTRATED SCREW, CANNULATED, Ø12MM x 40MM, SACROFUSE |
| 00190361035848 | FENESTRATED SCREW, CANNULATED, Ø12MM x 30MM, SACROFUSE |
| 00190361023647 | DRIVER, GEN II INSERTER, SACROFUSE |
| 00190361023630 | STYLET, GEN II INSERTER, SACROFUSE |
| 00190361023623 | Ø14MM SLOTTED FUSION SCREW, GEN II, SACROFUSE, 70MM |
| 00190361023616 | Ø14MM SLOTTED FUSION SCREW, GEN II, SACROFUSE, 65MM |
| 00190361023609 | Ø14MM SLOTTED FUSION SCREW, GEN II, SACROFUSE, 60MM |
Trademark Results [SacroFuse]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SACROFUSE 86879981 5079908 Live/Registered |
SpineFrontier, Inc. 2016-01-19 |
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