| Primary Device ID | 00818345028678 |
| NIH Device Record Key | ae604bdb-fbb0-48aa-8e02-2779d5457bb4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SOLACE Sacroiliac Fixation System |
| Version Model Number | SS1-A2-000107 |
| Company DUNS | 080386764 |
| Company Name | Ht Medical, 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 | 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 |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818345028678 [Primary] |
| OUR | Sacroiliac Joint Fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00818345028678]
Moist Heat or Steam Sterilization
[00818345028678]
Moist Heat or Steam Sterilization
[00818345028678]
Moist Heat or Steam Sterilization
[00818345028678]
Moist Heat or Steam Sterilization
[00818345028678]
Moist Heat or Steam Sterilization
[00818345028678]
Moist Heat or Steam Sterilization
[00818345028678]
Moist Heat or Steam Sterilization
[00818345028678]
Moist Heat or Steam Sterilization
[00818345028678]
Moist Heat or Steam Sterilization
[00818345028678]
Moist Heat or Steam Sterilization
[00818345028678]
Moist Heat or Steam Sterilization
[00818345028678]
Moist Heat or Steam Sterilization
[00818345028678]
Moist Heat or Steam Sterilization
[00818345028678]
Moist Heat or Steam Sterilization
[00818345028678]
Moist Heat or Steam Sterilization
[00818345028678]
Moist Heat or Steam Sterilization
[00818345028678]
Moist Heat or Steam Sterilization
[00818345028678]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-27 |
| Device Publish Date | 2023-11-17 |
| 00818345029057 | SI Mallet |
| 00818345028982 | Nav SI Tap 8mm |
| 00818345028975 | 12mm SI Tap |
| 00818345028951 | 10mm SI Tap |
| 00818345028937 | 8mm SI Tap |
| 00818345028920 | 12 Implant Guide to Pin Guide, 21mm |
| 00818345028913 | 12 Implant Guide to Pin Guide, 20mm |
| 00818345028906 | 12 Implant Guide to Pin Guide, 19mm |
| 00818345028890 | 12 Implant Guide to Pin Guide, 18mm |
| 00818345028883 | 12 Implant Guide to Pin Guide, 17mm |
| 00818345028876 | 12 Implant Guide to Pin Guide, 16mm |
| 00818345028869 | 12 Implant Guide to Pin Guide, 15mm |
| 00818345028852 | 10.5 Implant Guide to Pin Guide, 21mm |
| 00818345028845 | 10.5 Implant Guide to Pin Guide, 20mm |
| 00818345028838 | 10.5 Implant Guide to Pin Guide, 19mm |
| 00818345028821 | 10.5 Implant Guide to Pin Guide, 18mm |
| 00818345028814 | 10.5 Implant Guide to Pin Guide, 17mm |
| 00818345028807 | 10.5 Implant Guide to Pin Guide, 16mm |
| 00818345028791 | 10.5 Implant Guide to Pin Guide, 15mm |
| 00818345028784 | Pin to pin guide, 21mm |
| 00818345028777 | Pin to pin guide, 20mm |
| 00818345028760 | Pin to pin guide, 19mm |
| 00818345028753 | Pin to pin guide, 18mm |
| 00818345028746 | Pin to pin guide, 17mm |
| 00818345028739 | Pin to pin guide, 16mm |
| 00818345028722 | Pin to pin guide, 15mm |
| 00818345028715 | 11mm SI Drill |
| 00818345028708 | 10mm SI Drill |
| 00818345028692 | 9mm SI Drill |
| 00818345028685 | 8mm SI Drill |
| 00818345028678 | 7mm SI Drill |
| 00818345028661 | Pin Template |
| 00818345028654 | 12mm Drill Sleeve |
| 00818345028647 | Pin Depth Measurement |
| 00818345028630 | Guide Handle |
| 00818345028623 | Implant Guide Impactor |
| 00818345028593 | Ø12 Implant Guide, Spike Tip |
| 00818345028586 | Ø12 Implant Guide |
| 00818345028579 | Ø10.5 Implant Guide, Spiked Tip |
| 00818345028562 | Ø10.5 Implant Guide |
| 00818345028555 | Steinmann Pin Dilator, Ø12 |
| 00818345028548 | Steinmann Pin Dilator, Ø10.5 |
| 00818345028531 | Pin and Dilator Holder |
| 00818345028524 | Cannula Clean Out Pin |
| 00818345028517 | Transfer Pin |
| 00818345028500 | Steinmann Pin, 360mm, Diamond |
| 00818345028494 | Steinmann Pin, 360mm, Bevel |
| 00818345028487 | Steinmann Pin, 300mm, Diamond |
| 00818345028470 | Steinmann Pin, 300mm, Bevel |
| 00818345028463 | Steinmann Pin, 225mm, Diamond |