Life Spine Laminoplasty System
FDA 510(k) clearance K181717 · decided 2018-10-12
Clearance details
- K-number
- K181717
- Device name
- Life Spine Laminoplasty System
- Applicant
- Life Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-06-28
- Decision date
- 2018-10-12
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- NQW
- Device class
- 2
- Regulation number
- 888.3050
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Huntley, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Life Spine
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| Choice Spine Laminoplasty™ Fixation System (K173215) | Choicespine, LP | 2018-01-19 |
| HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System (K171413) | Globus Medical, Inc. | 2017-07-14 |
| 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.