Identity
- Trade Name
- RIALTO™ SI FUSION SYSTEM FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- DEVICE 74200001260 THREADED 12X60 FDA UDI
- Model / Reference
- 74200001260 FDA UDI
- Description
- DEVICE 74200001260 THREADED 12X60 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169571860 FDA UDI
- 510(k) Number
- K161210 FDA UDI
- FDA Product Code
- OUR FDA UDIHWE FDA UDIOLO FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI878.4820 FDA UDI882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Category: Orthopaedic bone screw (non-sliding)
Rialto™ Si Fusion System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
- EVOS — Smith & Nephew, Inc. · Class II
- TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Zavation — ZAVATION · Class II
- STARDRIVE — Synthes GmbH · Class IIb
- Arthrex® — Arthrex, Inc. · Class II
- Cancellous Screw, Locking — I.T.S. GmbH · Class II
- PANGEA — Stryker Corp. · Class II
Cleared under the same submission
K161210 also covers:
- Medtronic Transportation/Sterilization Cassette — MEDTRONIC SOFAMOR DANEK, INC.
- RIALTO™ SI FUSION SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- RIALTO™ SI FUSION SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- RIALTO™ SI FUSION SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- RIALTO™ SI FUSION SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- RIALTO™ SI FUSION SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- RIALTO™ SI FUSION SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- RIALTO™ SI FUSION SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- RIALTO™ SI FUSION SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- RIALTO™ SI FUSION SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- RIALTO™ SI FUSION SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- RIALTO™ SI FUSION SYSTEM — MEDTRONIC SOFAMOR DANEK, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI 01a2b992-870d-4faa-960a-00f0ebd3a411 36 fields · synced Jun 8, 2026