Universal Navigation Adaptor Set
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Universal Navigation Adaptor Set EUDAMEDN/A FDA UDI
- Generic Name
- Surgical optical-tracking spatial marker connector FDA UDI
- Device Name
- UNAS Universal Navigation Adaptor Set Navigation Ring EUDAMEDUNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION RING diameter 22 FDA UDI
- Model / Reference
- UNAS Universal Navigation Adaptor Set Ring EUDAMED302011022 EUDAMEDFDA UDI
- Description
- UNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION RING diameter 22 FDA UDI
Identifiers
- Catalog Number
- 302011022 FDA UDI
- Primary DI / UDI-DI
- 10705034536170 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705034a000125B EUDAMED
- Direct Marketing DI
- 10705034536170 EUDAMED
- 510(k) Number
- K212756 FDA UDI
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z12130480 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Surgical optical-tracking spatial marker connector FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Multi-purpose stereotactic surgery system
Universal Navigation Adaptor Set by Medos International Sarl — Class I — MDR, FDA UDI — listed in EUDAMED, 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
- PEEK INSTRUMENT ADAPTOR Ø4.6MM — MEDTECH LLC · Class II
- Mo¨ller® — MEDTRONIC NAVIGATION, INC. · Class II
- StealthStation® S7® — MEDTRONIC NAVIGATION, INC. · Class II
- NIM-Spine — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- Stealth Autoguide™ System — MEDTRONIC NAVIGATION, INC. · Class II
- Stealth Station® S7™ — MEDTRONIC NAVIGATION, INC. · Class II
- ROSA® KNEE PERSONA® ID PLATE — Zimmer CAS · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0705034a000125B | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medos International SARL
- EUDAMED SRN
- CH-MF-000014268
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (2)
- EUDAMED e6f6a3b4-15cc-412e-b421-2ad21b03d435 61 fields · synced Jul 29, 2026
- FDA UDI 28731389-0b58-4553-9a9a-98fa989b9f62 36 fields · synced May 30, 2026