FDA UDI
In Commercial Distribution
🇺🇸 United States
SOLACE Sacroiliac Fixation System
DI: 00818345029545
·
Model: SS1-A1-000093
·
XENIX MEDICAL LLC
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SOLACE Sacroiliac Fixation System
- Primary DI
- 00818345029545
- Version / Model
- SS1-A1-000093
- Catalog Number
- SS1-A1-000093
- Company Name
- XENIX MEDICAL LLC
- Labeler DUNS
- 080386764
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-05
- Public Version
- 2
- Public Version Date
- 2025-07-18
- Public Version Status
- Update
- Public Device Record Key
- 864592fd-9f2f-491e-bb3d-248a0883b4d8
Device Description
Measuring Dilator, 12mm, Radiolucent
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OUR | Sacroiliac Joint Fixation | Orthopedic | 888.3040 | 2 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | 882.4560 | 2 |
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58849 | Sacroiliac joint transarticular fixation/arthrodesis implantation kit | A collection of surgical instruments and devices intended to be used for the implantation of a sacroiliac joint transarticular fixation/arthrodesis implant during a minimally-invasive procedure. It typically consists of a tray, dedicated soft-tissue protectors, depth gauges, pin sleeves, drill sleeves, drill bits, broaches, a parallel pin guide, handles, slide hammer shafts, impactors, and a removal/adaptor tool; the implant(s) is not included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00818345029545 | GS1 |
Customer Contacts
- Phone
- 888-594-8633
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231829 | 000 |