THE ARTAS SYSTEM FROM RESTORATION ROBOTICS
FDA 510(k) clearance K103428 · decided 2011-04-04
Clearance details
- K-number
- K103428
- Device name
- THE ARTAS SYSTEM FROM RESTORATION ROBOTICS
- Applicant
- Restoration Robotics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-11-22
- Decision date
- 2011-04-04
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- ONA
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ARTAS System (K173358) | Restoration Robotics, Inc. | 2018-03-16 |
| THE ARTAS SYSTEM (K123548) | Restoration Robotics, Inc. | 2013-02-25 |
| ARTAS SYSTEM FROM RESTORATION ROBOTICS (K123154) | Restoration Robotics, Inc. | 2013-02-19 |
Recalls involving this device
No recalls on record reference this clearance.