Identity
- Trade Name
- 8” Tablet FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Model / Reference
- ACC00310 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290113780712 FDA UDI
- 510(k) Number
- K211188 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Multi-purpose stereotactic surgery system 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
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: Multi-purpose stereotactic surgery system
8” Tablet by Augmedics Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-purpose stereotactic surgery system.
- PEEK INSTRUMENT ADAPTOR Ø2.15MM — MEDTECH LLC · Class II
- TRIALTIS Spine System — MEDOS INTERNATIONAL SARL · Class IIa
- PEEK INSTRUMENT ADAPTOR Ø4.6MM — MEDTECH LLC · Class II
- Mo¨ller® — MEDTRONIC NAVIGATION, INC. · Class II
- StealthStation® S7® — MEDTRONIC NAVIGATION, INC. · Class II
- NIM-Spine — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- UNIVERSAL NAVIGATION VIPER SYSTEM — MEDOS INTERNATIONAL SARL · Class IIa
- NAVIGATION ENABLED INSTRUMENTS — MEDOS INTERNATIONAL SARL · Class IIa
Cleared under the same submission
K211188 also covers:
- 8” Tablet Docking — AUGMEDICS LTD.
- Augmedics WS-Cart assembly — AUGMEDICS LTD.
- Perc Insertion Cap — AUGMEDICS LTD.
- Perc Mallet 250 gr. — AUGMEDICS LTD.
- Perc Pin 100mm 5 units Package — AUGMEDICS LTD.
- Perc Pin 125mm 5 units Package — AUGMEDICS LTD.
- Perc Pin 150mm 5 units Package — AUGMEDICS LTD.
- Perc Pin Adaptor — AUGMEDICS LTD.
- Perc Pin Tray — AUGMEDICS LTD.
- Perc Schanz Screw Adaptor Short — AUGMEDICS LTD.
- Perc Slap Hammer — AUGMEDICS LTD.
- Rotating Marker Adaptor — AUGMEDICS LTD.
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
- Augmedics Ltd.
Sources (1)
- FDA UDI 0f7f3e97-1232-4a23-95f8-8cfec89f0d5d 33 fields · synced May 30, 2026