Optimized Positioning System (OPS) Insight
FDA 510(k) clearance K202805 · decided 2020-11-20
Clearance details
- K-number
- K202805
- Device name
- Optimized Positioning System (OPS) Insight
- Applicant
- Corin USA
- Decision
- Substantially Equivalent
- Date received
- 2020-09-23
- Decision date
- 2020-11-20
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Tampa, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Cormet Hip Resurfacing System (P050016/S012) | Corin USA | 2020-07-17 |
| CORMET HIP RESURFACING SYSTEM (P050016/S011) | Corin USA | 2016-12-21 |
| CORMET HIP RESURFACING SYSTEM (P050016/S010) | Corin USA | 2014-04-03 |
| CORMET HIP RESURFACING SYSTEM (P050016/S009) | Corin USA | 2013-03-22 |
| CORMET HIP RESURFACING SYSTEM (P050016/S008) | Corin USA | 2011-11-10 |
| CORMET HIP RESURFACING SYSTEM (P050016/S007) | Corin USA | 2011-01-13 |
| CORMET HIP RESURFACING SYSTEM (P050016/S006) | Corin USA | 2009-12-31 |
| CORMET HIP RESURFACING SYSTEM (P050016/S005) | Corin USA | 2009-12-03 |