Identity
- Trade Name
- SI-RESTORE FDA UDI
- Generic Name
- Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated FDA UDI
- Device Name
- SI-RESTORE SCREW, 11.0MM x 45MM FDA UDI
- Model / Reference
- 1701-111045 FDA UDI
- Description
- SI-RESTORE SCREW, 11.0MM x 45MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850073363096 FDA UDI
- 510(k) Number
- K182919 FDA UDI
- FDA Product Code
- HWC FDA UDIOUR 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 UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 45 Millimeter FDA UDIOuter Diameter — 11.0 Millimeter FDA UDI
Category: Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
Si-Restore by Biofusion Management And Manufacturing, Llc — 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
- SOLACE Sacroiliac Fixation System — Xenix Medical · 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
Cleared under the same submission
K182919 also covers:
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
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 |
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Manufacturer
- Manufacturer
- Biofusion Management And Manufacturing, Llc
Sources (1)
- FDA UDI d85facdf-2a4d-426e-a48c-7f6125bed1ff 35 fields · synced May 30, 2026