CANOPY LAMINOPLASTY FIXATION SYSTEM
FDA 510(k) clearance K121732 · decided 2012-10-31
Clearance details
- K-number
- K121732
- Device name
- CANOPY LAMINOPLASTY FIXATION SYSTEM
- Applicant
- Globus Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-06-13
- Decision date
- 2012-10-31
- Days to decision
- 140 days
- Clearance type
- Special
- Product code
- NQW
- Device class
- 2
- Regulation number
- 888.3050
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Audubon, PA, US
- Third-party review
- No
- Expedited review
- No
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| Centerpiece Plate Fixation System (K212428) | Medtronic Sofamor Danek | 2021-12-13 |
| Hinged Laminoplasty System (K191927) | Life Spine, Inc. | 2019-09-20 |
| NuVasive® Camber Laminoplasty System (K191169) | Nu Vasive, Incorporated | 2019-07-03 |
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| HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System (K171413) | Globus Medical, Inc. | 2017-07-14 |
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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 |