Identity
- Trade Name
- REAL INTELLIGENCE FDA UDI
- Generic Name
- Multi-purpose surgical power tool system, line-powered FDA UDI
- Device Name
- REAL INTELLIGENCE ROBOTIC DRILL FDA UDI
- Model / Reference
- ROB10013 FDA UDI
- Description
- REAL INTELLIGENCE ROBOTIC DRILL FDA UDI
Identifiers
- Catalog Number
- ROB10013 FDA UDI
- Primary DI / UDI-DI
- 00885556757321 FDA UDI
- 510(k) Number
- K201022 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Multi-purpose surgical power tool system, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Multi-purpose surgical power tool system, line-powered
Real Intelligence by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-purpose surgical power tool system, line-powered.
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- VELOCITY ALPHA ™ — adeor Medical AG · Class II
- VELOCITY ALPHA ™ — adeor Medical AG · Class II
- VELOCITY ALPHA ™ — adeor Medical AG · Class II
- VELOCITY ALPHA ™ — adeor Medical AG · Class II
- VELOCITY ALPHA ™ — adeor Medical AG · Class II
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- VELOCITY ALPHA ™ — adeor Medical AG · Class II
Cleared under the same submission
K201022 also covers:
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- Real Intelligence — Smith & Nephew, Inc.
- Real Intelligence — Smith & Nephew, Inc.
- Real Intelligence — Smith & Nephew, 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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 68fb4009-b759-44fb-a795-4245e6450cd8 36 fields · synced Jun 8, 2026