Identity
- Trade Name
- Robotic, Tool Holder Dia. 6 mm FDA UDI
- Generic Name
- Surgical optical-tracking spatial marker connector FDA UDI
- Model / Reference
- A40004 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701311500230 FDA UDI
- 510(k) Number
- K221028 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Surgical optical-tracking spatial marker connector 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
Yes
FDA UDI
Dry Heat Sterilization FDA UDI
Robotic, Tool Holder Dia. 6 mm by Ecential Robotics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K221028 also covers:
- 3.5 mm Hex Head Screwdriver — ECENTIAL ROBOTICS
- 3DSRW Software — ECENTIAL ROBOTICS
- CoBot — ECENTIAL ROBOTICS
- CoBot, Drill Bit — ECENTIAL ROBOTICS
- CoBot, Drill Guide – Cortical tip — ECENTIAL ROBOTICS
- CoBot, Drill Guide – Sleeve — ECENTIAL ROBOTICS
- CoBot, Spine Instruments tray — ECENTIAL ROBOTICS
- CoBot, Tool Holder — ECENTIAL ROBOTICS
- Fixation screw — ECENTIAL ROBOTICS
- Navigated Targeting Needle SPX1, Bevel Tip - 11G, 125mm — ECENTIAL ROBOTICS
- Navigated Targeting Needle SPX1, Trocar tip – 11G, 125 mm — ECENTIAL ROBOTICS
- Navigation set SPX1, Targeting Needle SPX1, Bevel Tip - 11G, 125 mm — ECENTIAL ROBOTICS
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
- Ecential Robotics
Sources (1)
- FDA UDI 1397147a-8c37-4e31-9e99-a49326fa5032 35 fields · synced May 29, 2026