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Navigation set SPX1, Targeting Needle SPX1, Trocar Tip - 11G, 125 mm
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Navigation set SPX1, Targeting Needle SPX1, Trocar Tip - 11G, 125 mm FDA UDI
- Generic Name
- Stereotactic surgery system probe, single-use FDA UDI
- Model / Reference
- A01029 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701311501077 FDA UDI
- 510(k) Number
- K221028 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Stereotactic surgery system probe, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone access cannulaStereotactic surgery system probe, single-useSurgical optical-tracking spatial marker, single-use
Navigation set SPX1, Targeting Needle SPX1, Trocar Tip - 11G, 125 mm by Ecential Robotics — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Surgical optical-tracking spatial marker, single-use.
- SkyWalker — MICROPORT NAVIBOT INTERNATIONAL LLC · Class II
- Mako — MAKO Surgical Corp. · Class II
- Navio — Smith & Nephew, Inc. · Class II
- Apollo Knee — CORIN LTD · Class II
- Icona Hip Stem — CORIN LTD · Class II
- Clear Guide TipTAG — Clear Guide Medical · Class I
- VELYS — Medos International Sàrl · Class II
- VELYS — Medos International Sàrl · Class II
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 43b7418d-1c0b-45d7-b010-001b604f7786 34 fields · synced May 31, 2026