Identity
- Trade Name
- SOLACE Sacroiliac Fixation System FDA UDI
- Generic Name
- Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated FDA UDI
- Device Name
- SI Implant, 10.5mm x 55mm FDA UDI
- Model / Reference
- SS1-32-010055 FDA UDI
- Description
- SI Implant, 10.5mm x 55mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818345028111 FDA UDI
- FDA Product Code
- OUR FDA UDIOLO FDA UDIHWC FDA UDI
- GMDN Term
- Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
SOLACE Sacroiliac Fixation System by Xenix Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated.
- DYNAMIS™ Implant System — PROMETHEAN RESTORATIVE · Class II
- DYNAMIS™ Implant System — PROMETHEAN RESTORATIVE · Class II
- DYNAMIS™ Implant System — PROMETHEAN RESTORATIVE · Class II
- SacroFuse — SPINEFRONTIER, INC. · Class II
- SI-LUTION Sacroiliac Joint Fusion System — Curiteva, LLC · Class II
- T-FIX™3Dsi Joint Fusion System — CUTTING EDGE SPINE · Class II
- Unity Erodium — Dio Medical Co., Ltd. · Class II
- DYNAMIS™ Implant System — PROMETHEAN RESTORATIVE · Class II
Cleared under the same submission
K231829 also covers:
- SOLACE Sacroiliac Fixation System — Xenix Medical
- SOLACE Sacroiliac Fixation System — Xenix Medical
- SOLACE Sacroiliac Fixation System — Xenix Medical
- SOLACE Sacroiliac Fixation System — Xenix Medical
- SOLACE Sacroiliac Fixation System — Xenix Medical
- SOLACE Sacroiliac Fixation System — Xenix Medical
- SOLACE Sacroiliac Fixation System — Xenix Medical
- SOLACE Sacroiliac Fixation System — Xenix Medical
- SOLACE Sacroiliac Fixation System — Xenix Medical
- SOLACE Sacroiliac Fixation System — Xenix Medical
- SOLACE Sacroiliac Fixation System — Xenix Medical
- SOLACE Sacroiliac Fixation System — Xenix Medical
K233241 also covers:
- SOLACE Sacroiliac Fixation System — Xenix Medical
- SOLACE Sacroiliac Fixation System — Xenix Medical
- SOLACE Sacroiliac Fixation System — Xenix Medical
- SOLACE Sacroiliac Fixation System — Xenix Medical
- SOLACE Sacroiliac Fixation System — Xenix Medical
- SOLACE Sacroiliac Fixation System — Xenix Medical
- SOLACE Sacroiliac Fixation System — Xenix Medical
- SOLACE Sacroiliac Fixation System — Xenix Medical
- SOLACE Sacroiliac Fixation System — Xenix Medical
- SOLACE Sacroiliac Fixation System — Xenix Medical
- SOLACE Sacroiliac Fixation System — Xenix Medical
- SOLACE Sacroiliac Fixation System — Xenix Medical
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xenix Medical
Sources (1)
- FDA UDI 1f5f4c15-26f6-4e16-bdda-3d307d8569f3 35 fields · synced Jun 8, 2026