Identity
- Trade Name
- Curve Navigation 17700 FDA UDI
- Generic Name
- Robotic surgical navigation system FDA UDI
- Model / Reference
- 17700 FDA UDI
Identifiers
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
Yes
FDA UDI
Category: Robotic surgical navigation systemElectromagnetic/optical surgical navigation device tracking system
Curve Navigation 17700 by Brainlab SE — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electromagnetic/optical surgical navigation device tracking system.
- Attachment Adapter Fix OT — Ortoma AB (Publ) · Class II
- Attachment Adapter Twin OT — Ortoma AB (Publ) · Class II
- Carto ENT — BIOSENSE WEBSTER (ISRAEL) LTD. · Class II
- OTS Hip Guide Reusable Set Pinnacle — Ortoma AB (Publ) · Class II
- Threaded Pin Driver — Ortoma AB (Publ) · Class II
- Pointer OT — Ortoma AB (Publ) · Class II
- Measurement Screw Driver — Ortoma AB (Publ) · Class II
- Reamer Adapter OTD — Ortoma AB (Publ) · Class II
Cleared under the same submission
K213989 also covers:
K223288 also covers:
K223864 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
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Brainlab SE
Sources (1)
- FDA UDI a796460c-a6e8-45a5-8dcd-930d34c2e734 33 fields · synced May 30, 2026