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iFuse Implant System-STP w/Outer Guide Pin Tubes (400149N)
FDA UDIClass I (US FDA UDI)
by Si-Bone Inc.
Identity
- Trade Name
- iFuse Implant System-STP w/Outer Guide Pin Tubes (400149N) FDA UDI
- Generic Name
- Orthopaedic implantation sleeve, reusable FDA UDI
- Device Name
- STP w/Outer Guide Pin Tubes (400149N) FDA UDI
- Model / Reference
- 400149N FDA UDI
- Description
- STP w/Outer Guide Pin Tubes (400149N) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851085007398 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic implantation sleeve, reusable 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
MR Conditional FDA UDI
Category: Orthopaedic implantation sleeve, reusable
iFuse Implant System-STP w/Outer Guide Pin Tubes (400149N) by Si-Bone Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic implantation sleeve, reusable.
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- Salvo® Spine System — Spine Wave, Inc. · Class I
- DRILL SLEEVE — Biomet Orthopedics, Inc. · Class I
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
- Si-Bone Inc.
Sources (1)
- FDA UDI 1f95a70e-9e09-4941-9e5a-ba868eb8c351 34 fields · synced May 30, 2026