Identity
- Trade Name
- Silex Sacroiliac Joint Fusion System FDA UDI
- Generic Name
- Sacroiliac joint transarticular fixation/arthrodesis implant, coated FDA UDI
- Device Name
- SILEX SACROILIAC LOCKING IMPLANT, SINGLE THREAD, 7mm DIA X 50mm FDA UDI
- Model / Reference
- X079-0750 FDA UDI
- Description
- SILEX SACROILIAC LOCKING IMPLANT, SINGLE THREAD, 7mm DIA X 50mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- M697X07907501 FDA UDI
- FDA Product Code
- OUR FDA UDI
- GMDN Term
- Sacroiliac joint transarticular fixation/arthrodesis implant, coated 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
- Outer Diameter — 7 Millimeter FDA UDILength — 50 Millimeter FDA UDI
Category: Sacroiliac joint transarticular fixation/arthrodesis implant, coated
Silex Sacroiliac Joint Fusion System by Xtant Medical Holdings, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sacroiliac joint transarticular fixation/arthrodesis implant, coated.
- SImmetry Implant, 12.5mm x 100mm — Paradigm Spine, LLC · Class II
- iFuse Granite Implant System — Si-Bone Inc. · Class II
- SImmetry Implant, 14.5mm x 75mm — Paradigm Spine, LLC · Class II
- M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System — Medacta International · Class II
- BowTie SI Fusion System — SAIL FUSION · Class II
- iFuse Bedrock Granite Implant System — Si-Bone Inc. · Class II
- SImmetry LAG Implant, 10.5mm x 105mm — Paradigm Spine, LLC · Class II
- SImmetry LAG Implant, 12.5mm x 90mm — Paradigm Spine, LLC · Class II
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
- Xtant Medical Holdings, Inc.
Sources (1)
- FDA UDI 83a5a714-e5a8-4120-95b6-bc5450c72611 35 fields · synced Jun 6, 2026