Identity
- Trade Name
- PLANNING STATION - ROSA ONE - USA FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- Planning Station DELL 7520 Qwerty power plug B for Rosa One FDA UDI
- Model / Reference
- 164017-02 FDA UDI
- Description
- Planning Station DELL 7520 Qwerty power plug B for Rosa One FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889024671102 FDA UDI
- 510(k) Number
- K231103 FDA UDI
- FDA Product Code
- HAW 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
Planning Station - Rosa One - Usa by Medtech Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multi-purpose stereotactic surgery system.
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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
- ROSA ONE BRAIN APPLICATION (US) — 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 |
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Manufacturer
- Manufacturer
- Medtech Llc
Sources (1)
- FDA UDI 8fa83820-9471-4294-93f5-39c1a2293fc4 35 fields · synced Jun 8, 2026