← Back to catalogue
T-handle, Ratcheting, Quarter Square, Low profile, 0.180 Cannula
FDA UDIClass I (US FDA UDI)
by Si-Bone Inc.
Identity
- Trade Name
- T-handle, Ratcheting, Quarter Square, Low profile, 0.180 Cannula FDA UDI
- Generic Name
- Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI
- Device Name
- T-handle, Ratcheting, Quarter Square, Low profile, 0.180 Cannula FDA UDI
- Model / Reference
- 501518 FDA UDI
- Description
- T-handle, Ratcheting, Quarter Square, Low profile, 0.180 Cannula FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810055522019 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
Yes
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
T-handle, Ratcheting, Quarter Square, Low profile, 0.180 Cannula by Si-Bone Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sacroiliac joint transarticular fixation/arthrodesis implantation kit.
- SAMBA SCREW SYSTEM — MEDICAL DESIGNS LLC · Class II
- Zavation Medical Products, LLC — ZAVATION · Class I
- BowTie SI Fusion System — SAIL FUSION · Class I
- BowTie SI Fusion System — SAIL FUSION · Class I
- 12mm Sleeve — OsteoCentric Technologies,Inc · Class I
- 4.0mm Drill Bit Cann Hud-Mod — OsteoCentric Technologies,Inc · Class I
- Xenix Medical Sacroiliac Fixation System — Xenix Medical · Class II
- Zavation Medical Products, LLC — ZAVATION · 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Si-Bone Inc.
Sources (1)
- FDA UDI b811fd1a-55fb-458d-95f9-4c7f9a288943 34 fields · synced May 30, 2026