Identity
- Trade Name
- SiLO TFX MIS Sacroiliac Joint Fixation System FDA UDI
- Generic Name
- Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI
- Device Name
- Guidepin Ø2.4mm x 280mm Smooth Sharp FDA UDI
- Model / Reference
- 110-364-2 FDA UDI
- Description
- Guidepin Ø2.4mm x 280mm Smooth Sharp FDA UDI
Identifiers
- Primary DI / UDI-DI
- B52111036420 FDA UDI
- 510(k) Number
- K221047 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Category: Sacroiliac joint transarticular fixation/arthrodesis implantation kit
SiLO TFX MIS Sacroiliac Joint Fixation System by Aurora Spine, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Sacroiliac joint transarticular fixation/arthrodesis implantation kit.
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Cleared under the same submission
K221047 also covers:
- SiLO TFX MIS Sacroiliac Joint Fixation System — AURORA SPINE, INC.
- SiLO TFX MIS Sacroiliac Joint Fixation System — AURORA SPINE, INC.
- SiLO TFX MIS Sacroiliac Joint Fixation System — AURORA SPINE, INC.
- SiLO TFX MIS Sacroiliac Joint Fixation System — AURORA SPINE, INC.
- SiLO TFX MIS Sacroiliac Joint Fixation System — AURORA SPINE, INC.
- SiLO TFX MIS Sacroiliac Joint Fixation System — AURORA SPINE, INC.
- SiLO TFX MIS Sacroiliac Joint Fixation System — AURORA SPINE, INC.
- SiLO TFX MIS Sacroiliac Joint Fixation System — AURORA SPINE, INC.
- SiLO TFX MIS Sacroiliac Joint Fixation System — AURORA SPINE, INC.
- SiLO TFX MIS Sacroiliac Joint Fixation System — AURORA SPINE, INC.
- SiLO TFX MIS Sacroiliac Joint Fixation System — AURORA SPINE, INC.
- SiLO TFX MIS Sacroiliac Joint Fixation System — AURORA SPINE, 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 I | Pending data |
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Manufacturer
- Manufacturer
- Aurora Spine, Inc.
Sources (1)
- FDA UDI 8aad31ca-20be-4a86-8b4c-5d1793c15b3b 35 fields · synced May 30, 2026