Identity
- Trade Name
- ROSA ONE BRAIN APPLICATION (US) FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- Standard ROSA® ONE Surgical Assistant device( including robot arm and stand , touch screen, support arm) 120 V - 60 Hz - Plug B FDA UDI
- Model / Reference
- 3.1.7 FDA UDI
- Description
- Standard ROSA® ONE Surgical Assistant device( including robot arm and stand , touch screen, support arm) 120 V - 60 Hz - Plug B FDA UDI
Identifiers
- Catalog Number
- ROSAS00203 FDA UDI
- Primary DI / UDI-DI
- 00887868585951 FDA UDI
- 510(k) Number
- K231103 FDA UDI
- FDA Product Code
- OLO FDA UDIHAW FDA UDI
- GMDN Term
- Multi-purpose stereotactic surgery 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
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
MR Unsafe FDA UDI
Category: Multi-purpose stereotactic surgery system
Rosa One Brain Application (us) by Medtech Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-purpose stereotactic surgery system.
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- UNIVERSAL NAVIGATION VIPER SYSTEM — MEDOS INTERNATIONAL SARL · Class IIa
- NAVIGATION ENABLED INSTRUMENTS — MEDOS INTERNATIONAL SARL · Class IIa
- Stealth Autoguide™ System — MEDTRONIC NAVIGATION, INC. · Class II
- Stealth Station® S7™ — MEDTRONIC NAVIGATION, INC. · Class II
Cleared under the same submission
K231103 also covers:
- ALLEN WRENCH 8MM — MEDTECH LLC
- CRW frame adaptor — MEDTECH LLC
- LEKSELL FRAME REGISTRATION PLATES — MEDTECH LLC
- Optical distance sensor — MEDTECH LLC
- PLANNING STATION - ROSA ONE - USA — MEDTECH LLC
- PLANNING STATION - ROSA ONE - USA — MEDTECH LLC
- Radiolucent support arm — MEDTECH LLC
- SEEG DRILL ADAPTOR 2.70MM — MEDTECH LLC
- TRANSNASAL ENDOSCOPY INTRUMENT HOLDER Ø 3, 9 mm — MEDTECH LLC
- TRANSNASAL ENDOSCOPY INTRUMENT HOLDER Ø 5, 1 mm — MEDTECH LLC
- Trnsnsl Endscp Ovoid Ø6.18mm Holder — MEDTECH 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtech Llc
Sources (1)
- FDA UDI 7ba1b759-788c-40c2-849b-1864cb392a96 36 fields · synced Jun 1, 2026