Identity
- Trade Name
- StealthStation S8 Platform FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- MAIN CART 9735666 STEALTH S8 BASIC FDA UDI
- Model / Reference
- 9735666 FDA UDI
- Description
- MAIN CART 9735666 STEALTH S8 BASIC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000360382 FDA UDI
- 510(k) Number
- K162309 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
Category: Multi-purpose stereotactic surgery system
StealthStation S8 Platform by Medtronic Navigation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-purpose stereotactic surgery system.
- PEEK INSTRUMENT ADAPTOR Ø2.15MM — MEDTECH LLC · Class II
- TRIALTIS Spine System — MEDOS INTERNATIONAL SARL · Class IIa
- PEEK INSTRUMENT ADAPTOR Ø4.6MM — MEDTECH LLC · Class II
- NIM-Spine — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- UNIVERSAL NAVIGATION VIPER SYSTEM — MEDOS INTERNATIONAL SARL · Class IIa
- NAVIGATION ENABLED INSTRUMENTS — MEDOS INTERNATIONAL SARL · Class IIa
- ROSA® KNEE PERSONA® ID PLATE — Zimmer CAS · Class I
- Standard xvision tray, instruments included — AUGMEDICS LTD. · Class II
Cleared under the same submission
K162309 also covers:
- Stealth S8 — MEDTRONIC NAVIGATION, INC.
- Stealth S8 — MEDTRONIC NAVIGATION, INC.
- StealthStation — MEDTRONIC NAVIGATION, INC.
- StealthStation — MEDTRONIC NAVIGATION, INC.
- StealthStation — MEDTRONIC NAVIGATION, INC.
- StealthStation — MEDTRONIC NAVIGATION, INC.
- StealthStation — MEDTRONIC NAVIGATION, INC.
- StealthStation — MEDTRONIC NAVIGATION, INC.
- StealthStation — MEDTRONIC NAVIGATION, INC.
- StealthStation — MEDTRONIC NAVIGATION, INC.
- StealthStation — MEDTRONIC NAVIGATION, INC.
- StealthStation — MEDTRONIC NAVIGATION, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Navigation, Inc.
Sources (1)
- FDA UDI f4f817ec-6120-4f78-8a6f-145acff0bb8e 35 fields · synced Jun 6, 2026