MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0
FDA 510(k) clearance K081867 · decided 2008-11-25
Clearance details
- K-number
- K081867
- Device name
- MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0
- Applicant
- Mako Surgical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2008-07-01
- Decision date
- 2008-11-25
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Fort Lauderdale, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist th recall (Z-0385-2013) | Mako Surgical Corporation | 2012-11-19 |
| 200996-Cable Assembly, Hybrid Extended Length, 200997 Cable Assembly, Hybrid, Guidance Mod recall (Z-0064-2010) | Mako Surgical Corporation | 2009-10-19 |