Identity
- Trade Name
- SacroFuse FDA UDI
- Generic Name
- Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated FDA UDI
- Device Name
- FENESTRATED SCREW, CANNULATED, Ø10MM x 65MM, SACROFUSE FDA UDI
- Model / Reference
- 01-42201-65 FDA UDI
- Description
- FENESTRATED SCREW, CANNULATED, Ø10MM x 65MM, SACROFUSE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190361036005 FDA UDI
- 510(k) Number
- K150017 FDA UDI
- FDA Product Code
- OUR 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 65 Millimeter FDA UDIOuter Diameter — 10 Millimeter FDA UDI
Category: Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
SacroFuse by Spinefrontier, Inc. — 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
- 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
K150017 also covers:
- SacroFuse — SPINEFRONTIER, INC.
- SacroFuse — SPINEFRONTIER, INC.
- SacroFuse — SPINEFRONTIER, INC.
- SacroFuse — SPINEFRONTIER, INC.
- SacroFuse — SPINEFRONTIER, INC.
- SacroFuse — SPINEFRONTIER, INC.
- SacroFuse — SPINEFRONTIER, INC.
- SacroFuse — SPINEFRONTIER, INC.
- SacroFuse — SPINEFRONTIER, INC.
- SacroFuse — SPINEFRONTIER, INC.
- SacroFuse — SPINEFRONTIER, INC.
- SacroFuse — SPINEFRONTIER, INC.
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
- Spinefrontier, Inc.
Sources (1)
- FDA UDI 2e3c7103-16be-4eea-86fb-cf6022af51bf 36 fields · synced May 31, 2026