Identity
- Trade Name
- RIO FDA UDI
- Generic Name
- Patient positioning sensor FDA UDI
- Device Name
- SYSTEM QUICK CONNECT BASE ARRAY FDA UDI
- Model / Reference
- 112220 FDA UDI
- Description
- SYSTEM QUICK CONNECT BASE ARRAY FDA UDI
Identifiers
- Catalog Number
- 112220 FDA UDI
- Primary DI / UDI-DI
- 00848486002916 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Patient positioning sensor 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
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: Patient positioning sensor
Rio by MAKO Surgical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient positioning sensor.
- NGENIUS — Stryker Leibinger · Class II
- EV1000 — Edwards Lifesciences LLC · Class II
- Sherlock — Bard Access Systems, Inc. · Class II
- Patient tracker EM-D mini — Scopis GmbH · Class II
- General Purpose Sensor — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Sherlock — Bard Access Systems, Inc. · Class II
- Sherlock — Bard Access Systems, Inc. · Class II
- Patient tracker EM mini — Scopis GmbH · Class II
Cleared under the same submission
K112507 also covers:
K121064 also covers:
- DYNASTY — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS — MAKO Surgical Corp.
- RESTORIS, PST, RIO — MAKO Surgical Corp.
- RESTORIS, PST, RIO — MAKO Surgical Corp.
- RESTORIS, PST, RIO — MAKO Surgical Corp.
- RESTORIS, RIO — MAKO Surgical Corp.
- RESTORIS, RIO — MAKO Surgical Corp.
- RESTORIS, RIO — MAKO Surgical Corp.
- RESTORIS, TRINITY, RIO — MAKO Surgical Corp.
- RESTORIS, TRINITY, RIO — MAKO Surgical Corp.
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
- MAKO Surgical Corp.
Sources (1)
- FDA UDI 9e361ccd-bba2-4c0e-ab0d-91a97b3a8a7c 35 fields · synced Jun 9, 2026