Identity
- Trade Name
- Kick 2 Navigation Station FDA UDI
- Generic Name
- Robotic surgical navigation system FDA UDI
- Model / Reference
- 18170 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481006655 FDA UDI
- FDA Product Code
- HAW FDA UDIOLO 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Kick 2 Navigation Station by Brainlab SE — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K092467 also covers:
K243698 also covers:
- Alignment Software Cranial with LITT — Brainlab AG
- Alignment Bone Anchor Cranial 2.1 mm / 4.9 mm — Brainlab SE
- Alignment Guide Tube Cranial 4.9 mm / 8.0 mm — Brainlab SE
- Alignment Reduction Tube Cranial 8.0 mm / 10.0 mm — Brainlab SE
- Cirq Arm System 2.0 — Brainlab SE
- Curve Navigation 17700 — Brainlab SE
- Drill Bit Cranial 4.5 mm /4.9 mm — Brainlab SE
- Drill Depth Stop Cranial 4.9 mm — Brainlab SE
- Sterilization Tray Cirq® Robotic Alignment LITT — Brainlab SE
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 SE
Sources (1)
- FDA UDI 8e8aa899-2958-4453-a16a-01c17ee111ec 34 fields · synced Jun 1, 2026