HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System
FDA 510(k) clearance K171413 · decided 2017-07-14
Clearance details
- K-number
- K171413
- Device name
- HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System
- Applicant
- Globus Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-05-15
- Decision date
- 2017-07-14
- Days to decision
- 60 days
- Clearance type
- Traditional
- 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AQUA Laminoplasty Systems (K252930) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-05-27 |
| Curiteva Porous PEEK Laminoplasty System (K243137) | Curiteva, Inc. | 2024-10-28 |
| Vy Spine™ VyLam™ Laminoplasty System (K242784) | Vy Spine, LLC | 2024-10-16 |
| Vy Spine™ VyLam™ Laminoplasty System (K232471) | Vy Spine, LLC | 2023-10-10 |
| Curiteva Laminoplasty System (K231232) | Curiteva, Inc. | 2023-06-28 |
| 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 |
| Life Spine Laminoplasty System (K181717) | Life Spine, Inc. | 2018-10-12 |
| Choice Spine Laminoplasty™ Fixation System (K173215) | Choicespine, LP | 2018-01-19 |
| Xspan Laminoplasty Fixation System (K160114) | X-Spine Systems, Inc. | 2016-03-15 |
| Release Laminoplasty Fixation System (K153735) | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2016-01-21 |
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 |