THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW SYSTEM
FDA 510(k) clearance K973425 · decided 1998-02-27
Clearance details
- K-number
- K973425
- Device name
- THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW SYSTEM
- Applicant
- Corin USA
- Decision
- Substantially Equivalent
- Date received
- 1997-09-10
- Decision date
- 1998-02-27
- Days to decision
- 170 days
- Clearance type
- Traditional
- Product code
- MNH
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Tampa, FL, US
- Third-party review
- No
- Expedited review
- No
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| HC Spinal System (K151362) | Hung Chun Bio-S Co., Ltd. | 2016-05-05 |
| Zavation Spinal System (K153404) | Zavation, LLC | 2016-04-21 |
| Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System (K160020) | Captiva Spine | 2016-03-02 |
| Spinal Inner Fixation System (K143013) | Changzhou Dingjian Medical Appliance Co., Ltd. | 2015-12-11 |
| Romeo posterior osteosynthesis system (K151695) | Spineart | 2015-09-10 |
| CapLOX II/TowerLOX Pedicle Screw System (K151116) | Captiva Spine | 2015-06-26 |
| Republic Spine Dark Star Spinal System (K150283) | Republic Spine, LLC | 2015-04-29 |
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 |