Identity
- Trade Name
- REMI Robotic Navigation System FDA UDI
- Generic Name
- Robotic surgical navigation system FDA UDI
- Device Name
- REMI 8.5 mm Cann. Dual Lead Tap FDA UDI
- Model / Reference
- 1385 FDA UDI
- Description
- REMI 8.5 mm Cann. Dual Lead Tap FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850026574722 FDA UDI
- 510(k) Number
- K202184 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Robotic surgical navigation system 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
Yes
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
Category: Robotic surgical navigation system
REMI Robotic Navigation System by Fusion Robotics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K202184 also covers:
- REMI Robotic Navigation System — Fusion Robotics, LLC
- REMI Robotic Navigation System — Fusion Robotics, LLC
- REMI Robotic Navigation System — Fusion Robotics, LLC
- REMI Robotic Navigation System — Fusion Robotics, LLC
- REMI Robotic Navigation System — Fusion Robotics, LLC
- REMI Robotic Navigation System — Fusion Robotics, LLC
- REMI Robotic Navigation System — Fusion Robotics, LLC
- REMI Robotic Navigation System — Fusion Robotics, LLC
- REMI Robotic Navigation System — Fusion Robotics, LLC
- REMI Robotic Navigation System — Fusion Robotics, LLC
- REMI Robotic Navigation System — Fusion Robotics, LLC
- REMI Robotic Navigation System — Fusion Robotics, LLC
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
- Fusion Robotics, LLC
Sources (1)
- FDA UDI 35143560-4158-4475-ac08-e51692138594 34 fields · synced May 30, 2026