CORRIDOR Fixation System
FDA 510(k) clearance K192744 · decided 2019-12-16
Clearance details
- K-number
- K192744
- Device name
- CORRIDOR Fixation System
- Applicant
- Globus Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-30
- Decision date
- 2019-12-16
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- MRW
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Audubon, PA, US
- Third-party review
- No
- Expedited review
- No
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| CORUS-LX Implant (K253190) | Providence Medical Technology, Inc. | 2025-11-20 |
| FFX Facet Fixation System (K252153) | Sc Medica | 2025-10-16 |
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SECURE®-C Cervical Artificial Disc (P100003/S008) | Globus Medical, Inc. | 2023-06-12 |
| SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S007) | Globus Medical, Inc. | 2017-08-18 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S006) | Globus Medical, Inc. | 2016-05-17 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S005) | Globus Medical, Inc. | 2014-12-18 |
| SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S004) | Globus Medical, Inc. | 2014-06-30 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S003) | Globus Medical, Inc. | 2014-05-08 |
| SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S002) | Globus Medical, Inc. | 2013-09-06 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S001) | Globus Medical, Inc. | 2013-03-15 |