SacroFuse®
GUDID 00190361039587
INSERTER, SACROFUSE
SPINEFRONTIER, INC.
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated| Primary Device ID | 00190361039587 |
| NIH Device Record Key | e7841d06-d5c3-4dba-92f0-e49f225c0eae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SacroFuse® |
| Version Model Number | 13-42000 |
| 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 | false |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190361039587 [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 |
[00190361039587]
Moist Heat or Steam Sterilization
[00190361039587]
Moist Heat or Steam Sterilization
[00190361039587]
Moist Heat or Steam Sterilization
[00190361039587]
Moist Heat or Steam Sterilization
[00190361039587]
Moist Heat or Steam Sterilization
[00190361039587]
Moist Heat or Steam Sterilization
[00190361039587]
Moist Heat or Steam Sterilization
[00190361039587]
Moist Heat or Steam Sterilization
[00190361039587]
Moist Heat or Steam Sterilization
[00190361039587]
Moist Heat or Steam Sterilization
[00190361039587]
Moist Heat or Steam Sterilization
[00190361039587]
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 | 2016-10-05 |
Devices Manufactured by SPINEFRONTIER, INC.
| 00190361029403 - SacroFuse | 2021-09-07 Ø8MM X 80 MM FUSION SCREW, GEN II, SCAROFUSE |
| 00190361029410 - SacroFuse | 2021-09-07 Ø8MM X 90 MM FUSION SCREW, GEN II, SCAROFUSE |
| 00190361029427 - SacroFuse | 2021-09-07 Ø8MM X 100 MM FUSION SCREW, GEN II, SCAROFUSE |
| 00190361029434 - SacroFuse | 2021-09-07 Ø8MM X 110 MM FUSION SCREW, GEN II, SCAROFUSE |
| 00190361029441 - SacroFuse | 2021-09-07 Ø8MM X 120 MM FUSION SCREW, GEN II, SCAROFUSE |
| 00190361029458 - SacroFuse | 2021-09-07 Ø8MM X 130 MM FUSION SCREW, GEN II, SCAROFUSE |
| 00190361029465 - SacroFuse | 2021-09-07 Ø10MM X 80MM SLOTTED FUSION SCREW, GEN II, SACROFUSE |
| 00190361029472 - SacroFuse | 2021-09-07 Ø10MM X 90MM SLOTTED FUSION SCREW, GEN II, SACROFUSE |
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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