MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM
FDA 510(k) clearance K121064 · decided 2012-06-06
Clearance details
- K-number
- K121064
- Device name
- MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM
- Applicant
- Mako Surgical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2012-04-06
- Decision date
- 2012-06-06
- Days to decision
- 61 days
- Clearance type
- Special
- Product code
- OLO
- 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 |
|---|---|---|
| Stryker Mako Vizadisc Hip Procedure Tracking Kit recall (Z-2925-2018) | Mako Surgical Corporation | 2018-08-24 |
| Robotic Arm Interactive Orthopedic System (RIO) recall (Z-1508-2016) | Mako Surgical Corporation | 2016-04-18 |
| Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# recall (Z-0224-2016) | Mako Surgical Corporation | 2015-11-05 |
| RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use recall (Z-0828-2015) | Mako Surgical Corporation | 2014-12-18 |
| RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument desi recall (Z-0829-2015) | Mako Surgical Corporation | 2014-12-18 |
| RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument design recall (Z-0830-2015) | Mako Surgical Corporation | 2014-12-18 |