Identity
- Trade Name
- SteathStation FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- SW 9735762 APP STLTH S8 v2.0.1 FDA UDI
- Model / Reference
- 9735762 FDA UDI
- Description
- SW 9735762 APP STLTH S8 v2.0.1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000532123 FDA UDI
- 510(k) Number
- K203639 FDA UDI
- FDA Product Code
- OLO FDA UDIHAW FDA UDIPGW 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multi-purpose stereotactic surgery system
SteathStation 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.
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- 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
K203639 also covers:
- Medtronic Navigation — MEDTRONIC NAVIGATION, INC.
- Medtronic Navigation — MEDTRONIC NAVIGATION, INC.
- Medtronic Navigation — MEDTRONIC NAVIGATION, INC.
- Medtronic Navigation — MEDTRONIC NAVIGATION, INC.
- Medtronic Navigation — MEDTRONIC NAVIGATION, INC.
- Medtronic Navigation — MEDTRONIC NAVIGATION, INC.
- Medtronic Navigation — MEDTRONIC NAVIGATION, INC.
- Medtronic Navigation — MEDTRONIC NAVIGATION, INC.
- Medtronic Navigation — MEDTRONIC NAVIGATION, INC.
- Medtronic Navigation — MEDTRONIC NAVIGATION, INC.
- Medtronic Navigation — MEDTRONIC NAVIGATION, INC.
- Medtronic Navigation — 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 |
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Manufacturer
- Manufacturer
- Medtronic Navigation, Inc.
Sources (1)
- FDA UDI 787d4942-5682-477e-87d0-27d861ef5af7 35 fields · synced Jun 6, 2026