Identity
- Trade Name
- Express Reference Fixation Bases FDA UDI
- Generic Name
- Robotic surgical navigation system FDA UDI
- Model / Reference
- 53120-05 FDA UDI
Identifiers
- Catalog Number
- 53120-05 FDA UDI
- Primary DI / UDI-DI
- 04056481001865 FDA UDI
- 510(k) Number
- K102990 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Robotic surgical navigation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- Not 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
Moist Heat or Steam Sterilization FDA UDI
Express Reference Fixation Bases by Brainlab AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K102990 also covers:
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
- Brainlab AG
Sources (1)
- FDA UDI bfb86585-ef41-48b1-9dfd-575d5d93f553 36 fields · synced Jun 6, 2026