Identity
- Trade Name
- RIALTO™ SI FUSION SYSTEM FDA UDI
- Generic Name
- Bone tap, reusable FDA UDI
- Device Name
- TAP 7426003 RIALTO 12MM FDA UDI
- Model / Reference
- 7426003 FDA UDI
- Description
- TAP 7426003 RIALTO 12MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169572577 FDA UDI
- 510(k) Number
- K161210 FDA UDI
- FDA Product Code
- OUR FDA UDIOLO FDA UDIHWE FDA UDI
- GMDN Term
- Bone tap, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI882.4560 FDA UDI878.4820 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: Bone tap, reusable
Rialto™ Si Fusion System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone tap, reusable.
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- Insite — TORNIER, INC. · Class I
- ReLine — Nuvasive, Inc. · Class I
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- Response 5.5/6.0 Spine System — ORTHOPEDIATRICS CORP. · Class I
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 |
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Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI f2ca0560-b3eb-4481-ae13-1d87f4464310 36 fields · synced Jun 8, 2026